ESRD Network 13 Medwatch Database
FDA Dialyzer Recall Notice
2012-02-16
Lot Codes:
8SU203 EXPIRATION DATE: 12/31/2011,
8SU204 EXPIRATION DATE: 12/31/2011,
8SU205 EXPIRATION DATE: 12/31/2011,
09DU02013 EXPIRATION DATE: 04/30/2012,
09DU02014 EXPIRATION DATE: 04/30/2012,
09DU02022 EXPIRATION DATE: 04/30/2012,
09NU02011 EXPIRATION DATE: 10/31/2012,
09PU02011 EXPIRATION DATE: 11/30/2012,
09SU02001 EXPIRATION DATE: 12/31/2012,
09SU02007 EXPIRATION DATE: 12/31/2012,
10AU02013 EXPIRATION DATE: 01/31/2013,
10CU02001 EXPIRATION DATE: 03/31/2013,
10EU02010 EXPIRATION DATE: 05/31/2013,
10EU02017 EXPIRATION DATE: 05/31/2013,
10HU02013 EXPIRATION DATE: 06/30/2013,
10HU02014 EXPIRATION DATE: 06/30/2013,
10LU02001 EXPIRATION DATE: 09/30/2013,
10LU02013 EXPIRATION DATE: 09/30/2013,
10LU02014 EXPIRATION DATE: 09/30/2013,
10LU02015 EXPIRATION DATE: 09/30/2013
AUDIANCE: Dialysis Unit Medical Directors, Nurse Managers, and Administrators
ISSUE: Optiflux F250NRe Hemodialyzers have increased risk of an internal blood leak
BACKGROUND: Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis
Catalog No. 0500325E
The Fresenius Optiflux F250NRe Hemodialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
RECOMMENDATIONS: Fresenius Medical Care North America contacted customers by telephone on December 27, 2011, and sent a Customer Notification letter dated December 27, 2011, via certified mail return receipts and fax - back requested to all affected customers.
Customers were instructed to examine your stock of dialyzers, and isolate and discontinue use of the before mentioned lots. If you have identified dialyzers from the recalled lots, please contact Customer Service for a Return Goods Authorization. We will pick up the product you currently have in stock and supply replacement product. All products for return will be picked up during your next scheduled Fresenius delivery. Promtly fill out the fax-back reply form attached to the notification. Please do not return used dialyzers.
For further questions, please call 1 (800) 662-1237.