—#106328

Product

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.

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K082414
Affected lot / code info: 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

Why it was recalled

Optiflux F250NRe Hemodialyzers have increased risk of an internal blood leak

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: Worldwide Distribution -- USA (nationwide) and the country of Canada.

Timeline

Recall initiated: 2011-12-27
Posted by FDA: 2012-01-20
Terminated: 2013-07-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106328. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.