Some Info about End Stage Renal Disease (ESRD)

RECALL NOTICES

LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.:

Class I Recall Due To Power Supply Failure

Audience: Emergency Medicine, Cardiology, Risk Manager
ISSUE: A failure on the power supply assembly can result in either “No DC power” or “No DC or AC power”. A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and no AC (line) power is available.
BACKGROUND: The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitor is designed for use by trained medical personnel in hospitals and clinic settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest. Approximately 42,943 devices were distributed worldwide between September 16, 2002 and September 27, 2007. These devices were manufactured from July 31, 2002 to September 19, 2007.
RECOMMENDATION: All affected power supplies will be updated. Customers are advised to keep the defibrillators in service and follow recommended daily Operator Checklist steps while service updates are scheduled. See Recall Notice for contact information.
Read the MedWatch safety alert, including a link to the FDA Class I Recall Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm217980.htm
Posted 07/02/2010

 

Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall

Audience: Emergency Medicine
[Posted 06/09/2010]
ISSUE: Defibtech, LLC, notified customers of a recall of 5,418 DBP-2800 Battery Packs used in the Lifeline AED and ReviveR AED (semi-automatic external defibrillators). When the AED is used with an affected battery pack, the AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy.
BACKGROUND: This recall affects all DBP-2800 Battery Packs shipped prior to June 4, 2007. The DBP-2800 battery packs affected by this recall have been distributed globally to fire departments, EMS, health clubs, schools, and other organizations.
RECOMMENDATION: The company has identified recommendations for the end customer to follow until the battery pack has been corrected, which allows the battery pack to remain in service. A copy of these recommendations is being mailed to all affected customers, and is available on the web at http://www.defibtech.com/batteryFA.
Read the complete MedWatch Safety Summary including a link to the firm press release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214916.htm
Posted 06/09/2010

FDA MedWatch – Intravenous Medications Manufactured by Claris: Recall due to contamination of products
*Metronidazole, Ciprofloxacin and Ondansetron sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels.*
*Audience: Pharmacists, Hospital Risk Managers*

FDA notified healthcare professionals not to use the intravenous medications, metronidazole, ciprofloxacin and ondansetron manufactured by Claris Lifesciences due to contamination. These products were all manufactured on the same manufacturing line and sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. The FDA received reports of floating matter in intravenous bags of metronidazole and ondansetron. Foreign matter should not be present in a sterile injectable product. Healthcare professionals should not use these products and should immediately remove them from their pharmacy inventories. Claris is initiating a recall of all lots of these products. FDA is further investigating the situation and will notify the public when new information becomes available. Please review the linked Public Health Alert for a list of the affected and recalled products.

Read the complete MedWatch 2010 Safety summary, including a link to the Public Health alert, at
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214034.htm
Posted 06/01/2010

FDA MedWatch – Baxter Colleague Infusion Pumps: FDA Ordering Recall
Audience: Hospital Risk Managers
FDA notified healthcare professionals and consumers that it has ordered Baxter to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 of those pumps currently in use. FDA is ordering Baxter to recall and destroy all Colleague infusion pumps, reimburse customers for the value of the recalled device, and assist in finding a replacement for these customers. Hospitals and other users of Baxter’s Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition.
Read the complete MedWatch 2010 Safety alert including links to the FDA News release and previous MedWatch alert, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210695.htm
Posted 05/04/2010

 

FDA MedWatch – Cardiac Science Automated External Defibrillators – Powerheart, Cardiovive, NK, Responder models: Class I Recall

Audience: Emergency Medical Personnel, Risk Managers
[UPDATED 04/27/2010] This update alerts users that Nihon Kohden (NK) and GE Responder models are also affected although they were not identified in earlier communications about this recall. In addition, Cardiac Science issued a software upgrade for the devices’ self tests on 02/24/10 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices. However, FDA’s review of the updated software indicates that it detects some but not all electrical component defects. Updated recommendations and complete list of affected models can be found in the 04/27/2010 Medical Device Update.
Read the complete MedWatch 2010 Safety alert including links to the original Class 1 recall notice and updated recommendations and other information, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205165.htm
Posted 04/28/2010

LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.
Audience: Emergency medical personnel, consumers
FDA notified healthcare professionals of a Class I recall of LIFEPAK 15 Monitor/Defibrillator manufactured and distributed between Marcy 26, 2009 and December 15, 2009. There is a potential for the device to unexpectedly:

  • Power Off then On by itself.
  • Power Off then NOT turn On.
  • Power Off by itself requiring the operator to turn it back On.
  • Stay powered On and not allow itself to be turned Off.

Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Online: www.fda.gov/MedWatch/report.htm1
  • Phone: 1-800-332-1088
  • Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch “Download Forms2” page, to address on the pre-addressed form
  • Fax: 1-800-FDA-0178

Read the complete MedWatch 2010 Safety summary, including a link to the Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm209467.htm
Posted 04/26/2010

Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall
Audience: Nephrology healthcare professionals, patients
FDA and Baxter notified healthcare professionals of a Class I recall of the HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems, which are prescription medical devices used to treat pediatric and adult patients with kidney failure. Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity. IIPV may result in serious injury or death from conditions including but not limited to: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function, pericardial effusion, and peritonitis.
Children and non-verbal patients may be at increased risk because of their smaller size or inability to communicate. Increased monitoring of these patients is recommended. Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.
Patients and caregivers should watch for the potential signs of IIPV. If patients or caregivers notice any of the signs of IIPV, stop the device, initiate manual drain, and contact your doctor immediately. Clinicians should weigh the risks and benefits to continued use of these devices by their patients versus other forms of dialysis therapy. Clinicians should also review the prescription settings for patients who continue to use these devices. See the Recall Notice for a listing of affected models/product code numbers.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202885.htm
Posted 03/03/2010

FDA MedWatch: OneTouch SureStep Test Strips (LifeScan): Recall
Audience: Diabetes healthcare professionals, consumers
LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
If patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.
The eight lots of consumer OneTouch SureStep Test Strips being recalled are identified in the firm’s press release. Lot numbers are located on the outer carton and test strip vial. LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010.
It is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher.
Read the complete MedWatch 2010 Safety summary, including a link to the firm’s press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202254.htm
Posted 03/01/2010

FDA MedWatch – Videx/Videx EC (didanosine): Labeling Revision – Risk of Non-Cirrhotic Portal Hypertension
 Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall
Audience: Emergency medical professionals, hospital risk managers
Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a recall because the automated external defibrillator (AED) may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. Each of the approximately 12,200 devices affected in this recall can be confirmed at the Cardiac Science Web site, www.cardiacscience.com/AED195. The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models – Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532 and CardioLife 9200G and 9231. Each affected AED should immediately be removed from service since it may not deliver the expected therapy.
Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200138.htm
Posted 02/10/2010

*Manufacturer’s Notice* This is NOT an FDA notice.
Spire HD Cath Recalls and Field Corrections
Posted 02/02/2010

FDA MedWatch – Edwards Lifesciences Aquarius Hemodialysis System: Recall – Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm
Audience: Nephrology and hemodialysis healthcare professionals, hospital risk managers
FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.
The recall includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. Baxter International, Inc. is the U.S. distributor of the Aquarius.
The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.
Read the complete MedWatch 2010 Safety summary, including a link to the FDA recall notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199203.htm
Posted 01/29/2010

FDA MedWatch – Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall
Exel/Exelint Huber needles,
Exel/Exelint Huber Infusion Sets
Exel/Exelint “Securetouch+” Safety Huber Infusion Sets
Audience: Hospital Risk Managers, Surgical Service personnel
FDA notified healthcare professionals of a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation due to ‘coring’, the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted. Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions.
Inspections conducted in October 2009 of Nipro facilities found that their needles “cored” in 60 to 72 percent of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate and will update the public if there are new developments.
Hospitals, clinics and patients who have needles from these lists should immediately stop using these affected products and return any unused products to Exelint International Corporation.
There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with “07,” “08,” “09,” and one of the product codes or catalog numbers noted in the FDA news release.
Read the complete MedWatch 2010 Safety summary, including a link to the FDA News Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198728.htm
Posted 01/26/2010

FDA – MedWatch – Nipro GlucoPro Insulin Syringes: Recall
Audience: Pharmacists, diabetes healthcare professionals, consumers
Nipro Medical Corporation and FDA notified healthcare professionals of a voluntary nationwide recall of all GlucoPro Insulin Syringes. These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection. This recall includes all product codes and lot numbers with expiration dates before 2011-11 (November 1, 2011). Product was distributed nationwide, including Puerto Rico. Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement.
Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198445.htm
Posted 01/25/2010

FDA MedWatch – McNeil Consumer Healthcare Over-The-Counter Products: Recall

Audience: Consumers, Pharmacists
[Posted 01/15/2010] McNeil and FDA notified healthcare professionals of an expansion of the December 2009 recall. McNeil Consumer Healthcare has now applied broader criteria to identify and remove all product lots that it believes may have the potential to be affected, even if they have not been the subject of consumer complaints. Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. The affected product lot numbers for the recalled products can be found on the side of the bottle label. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197740.htm
Posted 01/15/2010

Tylenol Arthritis Pain Caplet 100 count: Recall of all lots
Audience: Consumers, Pharmacists
McNeil Consumer Healthcare and FDA notified consumers that it is expanding a voluntary recall to include all available product lots of TYLENOL Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers provided in press release at link below). In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the presence of a chemical 2,4,6-tribromoanisole, believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious. Consumers who purchased TYLENOL Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement.
Read the complete MedWatch 2009 Safety summary, including a link to the firm’s press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm195704.htm
Posted 12/29/2009

Cleviprex (clevidipine butyrate): Recall of injectable emulsion due to presence of particulate matter
Audience: Pharmacists, risk managers
The Medicines Company and FDA notified healthcare professionals of a nationwide recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion, indicated for treatment of hypertension, due to the potential presence of particulate matter found to be inert stainless steel particles. If the particles were to aggregate, or if larger particles were present, then they could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.
See the company press release for information on specific lots affected by this recall.
Any adverse events that may be related to use should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch “Download Forms” page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm194585.htm
Posted 12/17/2009

FDA Medwatch – Accusure Insulin Syringes (Qualitest Pharm) – Nationwide recall of all lots due to potential for needle to become detached from syringe
Accusure Insulin Syringes (Qualitest Pharmaceuticals) – Recall
Audience: Diabetes healthcare professionals and patients
Qualitest Pharmaceuticals and FDA notified healthcare professionals of a nationwide recall of Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection. Consumers who have any Accusure insulin syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement.
Read the complete MedWatch 2009 Safety summary, including a link to the firm’s press release and previous August 2009 recall, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188151.htm

Posted 10/28/2009

FDA MedWatch – Philips Heartstart Fr2+ Automated External Defibrillators – Recall
Audience: Fire departments, emergency medical services personnel, hospitals
Philips and FDA notified healthcare professionals of the recall of 5,400 HeartStart FR2+ automated external defibrillators (AED) due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated. The AEDs are used by trained responders and designated response teams to help treat sudden cardiac arrest.
The recalled units (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) were manufactured between May, 2007 and January, 2008. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs and set up a page on the Philips Web site — www.philips.com/FR2PlusAction — with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is.
Read the complete MedWatch 2009 Safety summary, including a link to the firm’s press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm185179.htm
Posted 10/06/2009

FDA Medwatch – Children’s and Infants’ Tylenol Oral Suspension Products – Recall
Audience: Consumers and Healthcare professionals
McNeil Consumer Healthcare and FDA notified consumers of a nationwide recall of certain Tylenol products as a precautionary measure because of potential manufacturing problems. The company initiated a recall of certain oral suspension products distributed between March 2008 and May 2008 due to the potential of bacteria in raw materials used to manufacture the finished product. There are no illnesses reported by patients using this product. The full list of recalled product lots can be accessed on the company’s website at
http://www.tylenolprofessional.com/assets/TYLENOL_Letter_091809.pdf.
McNeil is advising parents and caregivers who have administered affected product to their child or infant and have concerns to contact their healthcare providers. Parents and caregivers can find the lot numbers on the bottom of the box containing the product and also on the sticker that surrounds the product bottle.
Read the complete MedWatch 2009 Safety summary including a link to the FDA news release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183924.htm
Posted 09/28/2009

MedWatch – Propafenone HCL Tabs: one lot recalled due to oversized tablets and risk of serious side effects
FDA and Watson Pharmaceuticals notified healthcare professionals and patients of a recall of Propafenone HCL 225 mg tablets, a drug product used to treat cardiac arrhythmias. The drug is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. Because it has a narrow therapeutic index, some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. The affected lot [lot number 112680A, expiration date July 31, 2010] of Propafenone HCL tablets was shipped to customers between October 15, 2008 and November 26, 2008. The Press Release includes instructions for identifying and returning the affected product.
Read the MedWatch safety summary, including a link to the company Press Release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Propafenone Posted 03/25/2009

MedWatch – Zencore Plus recalled due to product containing undeclared drug
Bodee LLC and FDA notified consumers and healthcare professionals of a nationwide recall of all the company’s supplement product sold under the name Zencore Plus. FDA lab analysis of Zencore Plus samples found the product contains benzamidenafil, an undeclared drug product and a PDE5 inhibitor. The use of Zencore Plus by an unsuspecting user of organic nitrates may pose a life-threatening risk of sudden and profound drop of blood pressure due to potential interaction between benzamidenafil and organic nitrates. Zencore Plus is sold in health food stores and by mail order on internet nationwide. Consumers who have this product in their possession should stop using it immediately.
Read the MedWatch safety summary, including a link to the company’s Press Release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Zencore

Posted 03/20/2009

FDA MedWatch – Welch Allyn AED 10 and and MRL JumpStart Defibrillators Class I recall
FDA and Welch Allen notified healthcare professionals and consumers of a nationwide Class I recall of 14,054 AED 10 and MRL JumpStart external defibrillators manufactured between October 3, 2002 and January 25, 2007. These devices may experience low energy shock, unexpected device shutdown, and/or susceptibility to electromagnetic noise interference. If such issues arise, it may prevent defibrillation of a patient in cardiac arrest and could lead to death. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. See the Recall Notice for additional instructions and contact information.
Read the MedWatch safety summary, including a link to the Recall Notice, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#AED10 Posted 03/16/2009

FDA Recall _ Fresenius Blood Tubing Set Recall
PRODUCT
a) CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device. Recall # Z-859-2009;
b) CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2794-0 Bonded CombiSets – includes priming set w/ needleless access port & Y-injection site bonded to arterial line, viral-retentive transducers and Twister device, Recall # Z-860-2009
CODE
a) Lot number: 8LR902;
b) Lot numbers: 8ER273, 8HR038, 8JR021, 8KR013, 8LR013, 8ER283, 8HR066, 8JR075, 8KR032, 8LR020, 8HR114, 8JR136, 8KR060, 8LR048, 8HR125, 8JR142, 8KR113, 8LR074, 8HR189, 8JR167, 8KR131, 8LR123, 8HR207, 8JR193, 8KR159, 8LR209, 8HR225, 8JR209, 8KR170, 8LR909, 8HR241, 8JR222, 8KR200, 8HR266, 8JR266, 8KR210, 8HR285, 8KR228, 8KR250, and 8KR271
RECALLING FIRM/MANUFACTURER
Fresenius Medical Care North America, Waltham, MA, by e-mail and telephone on November 25, 3008, and by letters on November 26, 2008, December 2, 2008 and December 3, 2008. Firm initiated recall is ongoing.
REASON
Port may crack and separate resulting in potential blood exposure/blood loss for the patient.
VOLUME OF PRODUCT IN COMMERCE
351,800 units
DISTRIBUTION
Nationwide and Canada Posted 02/9/2009

MedWatch – Ethex Corp. recalls prescription prenatal vitamin and iron supplement products
Nationwide recall expanded to include various prescription prenatal vitamin and iron supplement products.
Read the MedWatch 2009 safety summary, including links to the Ethex Press Releases, at
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Ethex Posted 02/9/2009

Single Lot of Epoetin Alfa Recalled Due to Damaged Vials POSTED 8/8/2008

Communication about HACH SteriChek “Sensitive” Total Chloramines and Residual Chlorine Reagent Strips that may have been shipped to your facility/office
Network 13 Letter
Network Follow up letter
Additional Information

Contact information for an additional supplier for reagent strips as needed for referral secondary to recall issues

RPC

Phone: 800.647.3873

Fax: 877.352.5557

Email: orders@rpc-rabrenco.com

Posted 7/23/2008, Updated 7/25/2008

MedWatch – 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product recalled: bacteria contamination
Sage Products informed healthcare professionals of the voluntary recall of limited lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product. The product was recalled because certain lots were found positive for Burkholderia cepacia (B. cepacia). B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as a weakened immune system or chronic lung diseases, particularly cystic fibrosis (CF) may be more susceptible to infections with B. cepacia. This organism is a known cause of infections in hospitalized patients and its effects range from no symptoms to serious respiratory infections, especially in patients with CF. The product was distributed to U.S. hospitals and medical centers nationwide and was shipped between 4/28/08 and 6/19/08. Healthcare professionals should stop using the product and coordinate the return of the product with the manufacturer.
Read the complete MedWatch 2008 Safety Summary, including a link to the firm press release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Chlorhexidine

Posted 7/1/2008

FDA MedWatch -Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula With Iron Powder- Product Recalled Because Of Oxidation
Abbott notified consumers and healthcare professionals of the recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder, a low-calcium and Vitamin D-free infant formula specifically designed for the nutritional support of infants and children with hypercalcemia. The product, distributed in the United States between 06/06/06 and 04/17/08, is being recalled because small amounts of air may have entered the can, resulting in product oxidation. Consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Parents should contact their healthcare professional if they have any questions or concerns.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer’s press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Calcilo

Posted 6/2/2008

FDA MedWatch- Solodyn (minocycline HCl) Extended Release Tablets: Recall Of Certain Lots Because One Bottle Of Solodyn Contained Azasan
Medicis and FDA notified healthcare professionals of the recall of lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of Solodyn Extended Release Tablets. The product was recalled because one of the bottles contained Azasan (azathioprine tablets) 75mg instead of Solodyn 90mg Tablets. Azasan is an immunosuppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking Azasan instead of Solodyn presents a health hazard and safety risk to patients. Side effects associated with the use of Azasan, particularly in the elderly, include myelosuppression, infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects. Additionally, unanticipated interactions with other drugs may also lead to serious adverse events. The recall is limited to the lots referenced above. Healthcare professionals are urged to check their inventory and pull the referenced lot numbers from their stock and make arrangements with the manufacturer to return the product.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer’s press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Solodyn

Posted 5/20/2008

FDA Heparin Recall
CMS Notification to All State Survey Agencies and Dialysis Facilities
FDA Bulletin
Network Letter
Posted 5/12/2008

FDA MedWatch- Cardinal Health Alcohol-Free Mouth- Product Recalled Because Of the Presence Of Burkholderia Cepacia
Hydrox Labs issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash because the product was found to contain Burkholderia cepacia (B. cepacia). The affected product lot number is 26228. B. cepacia poses little medical risk to healthy individuals. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with this organism. Consumers and facilities with the recalled alcohol-free mouthwash should stop using the product and contact Cardinal Health for instructions on how to return the product.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer’s press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Cardinal

POSTED 5/8/2008

FDA MedWatch- Digitek (digoxin tablets)-Class I Recall Because Tablets May Contain Twice The Approved Level Of Active Ingredient
Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer’s press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Digitek POSTED 5/2/2008

FDA MedWatch – Heparin Sodium USP – Voluntary Nationwide Recall Because Two Lots Had Heparin-like Contaminant
Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. See the manufacturer’s press release for the list of specific lots of the product affected by the recall. Use of the recalled product should be discontinued immediately. Patients should contact their physician if they experience any problems associated with the use of the product.Read the complete MedWatch 2008 safety summary, including a link to the firm press release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#heparinsodium POSTED 4/2/2008

Letter from Network 13 – Updated March 2008 FDA Notice Braun Heparin Recall POSTED 3/24/2008

MedWatch – Medtronic Neuromodulation Implantable Infusion Pumps: Class I recall – Reports of inflammatory mass formations
FDA and Medtronic notified healthcare professionals of the Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps, implantable devices for administering drugs to a specific site in the body to treat pain, spasticity and cancer. The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 28, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps. Medtronic’s representatives will complete a reply card to document their communication with each doctor regarding this recall, as well as asking the doctors to sign and return a reply card.
Read the complete MedWatch safety summary, including links to the Recall Notice and the “Dear Healthcare Professional” letter, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Neuromodulation POSTED 3/24/2008

Letter From Network 13 – Updated Heparin Recall Information Posted 3/3/2008

FDA MedWatch – Heparin Sodium Injection: Recall of Multi-dose And Single-dose Vials – Read the MedWatch 2008 safety summary, including links to the Public Health Update, press release, and the previous safety alert information, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2 POSTED 3/3/2008

Memo from Network regarding the Updated FDA Alert: Heparin Recall POSTED 2/12/2008

FDA MedWatch – Heparin Sodium Injection – Serious Adverse Events Reported In Patients Receiving Bolus Doses Of Medication
http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2 POSTED 2/11/2008

FDA MedWatch- Medtronic Inc. SnychroMed EL Implantable Infusion Pump – Class I Recall
FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories. The models were recalled because there is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors manufactured before September 1999. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient’s symptoms, and/or symptoms of drug under infusion or withdrawal. Healthcare professionals and patients with questions should contact the manufacturer.
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Class I Recall Notice regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#SynchroMed POSTED 2/4/2008

FDA Notices – Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ml 10 and 30ml Multi-Dose Vials Posted 2/4/2008

Recall of Baxter heparin following reports of allergic-type reactions among dialysis and other patients in multiple states POSTED 1/21/2008 (New)

Network 13 Memo to facilities regarding Heparin Recall POSTED 1/21/2008 (New)

FDA MedWatch – Heparin Sodium Injection 1000 units/mL recalled due to multiple adverse reactions reported POSTED 1/21/2008 (New)

 

CMS – Survey & Certification letter 07-34 “Survey Guidance for a New Home Hemodialysis Water Treatment Device, the “NxStage PureFlow™ SL Water Purification System (PureFlow™)” regarding the use of a new water treatment system called PureFlow with the NxStage dialysis equipment.

Copy of the recall letter from NxStage sent to their customers about the leaking cartridges
Posted 9/5/2007 – UPDATED 9/6/2007

Baxter Healthcare Corp. Recalls Baxter COLLEAGUE And FLO-GARD Volumetric Infusion Pumps Because Of Falsification Of Service And Repair Data
Baxter Healthcare and FDA notified healthcare professionals and consumers of a Class I Recall of Baxter COLLEAGUE and FLO-GARD Volumetric Infusion Pumps, Model numbers 2M8151 and 2M8153, COLLEAGUE CX Volumetric Infusion Pumps, Model numbers 2M8161 and 2M8163, and FLO-GARD Volumetric Infusion Pumps Model numbers 2M8063 and 2M8064.
The products were recalled because the firm identified repair, inspection, test data sheets, which included electrical safety data for the pumps, that were falsified. As a result it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them. This may result in over/under infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in line and malfunctions where the pump will stop infusing and result in an interruption of therapy that can lead to death. Return the affected pumps to Baxter Healthcare for repeat inspections and servicing. COLLEAGUE and FLO-GARD customers with questions should contact Baxter Healthcare Corp. at 1-800-422-4770.
Read the completed MedWatch 2007 Safety Summary including a link to the Recall notice at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#pumps Updated 7/30/2007

Azathioprine [Roxane] tablets recalled due to packing mix-up with Methotrexate
MedWatch – The FDA Safety Information and Adverse Event Reporting Program
Roxane Laboratories and FDA notified pharmacists and other healthcare professionals of a nationwide recall of a single manufacturing lot of Azathioprine tablets, 50 mg (Lot 558470A, Exp Mar 2009) used to help prevent rejection in kidney transplant patients, and to manage severe rheumatoid arthritis. The recall was initiated due to concerns that bottles from this single lot # 558470A, labeled as Azathioprine may contain Methotrexate, 2.5 mg tablets. Information has been sent to pharmacists alerting them of the details pertaining to this recall. Pharmacists who may have dispensed Azathioprine tablets to patients from manufacturing lot 558470A are instructed to contact those patients to assure they did not inadvertently receive Methotrexate tablets.

Getting Drugs After the Transition Period
CMS – TRANSITION FACT SHEET:
http://www.cms.gov/apps/media/press/release.asp?Counter=1817 POSTED 4/10/2006

 

Warning for Icodextrin Extraneal Dialysis Solution
Serious problem for ESRD patients’ glucoses while on Icodextrin Extraneal dialysis solution, and the effects of falsely elevated glucoses because of interaction of maltose using some glucometers? The FDA page link is http://www.fda.gov/cder/consumerinfo/druginfo/extraneal.htm – see the special warning section.
POSTED 4/18/2003

US Food and Drug Administration – Class 1 Recall: Ortho-Clinical Diagnostics VITROS® Immunodiagnostic HBsAg Confirmatory Kit

POSTED 1/10/2006