Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
FDA Recall Z-1339-2012 · Posted 2012-03-30
Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2012-03-06
Date Terminated2016-08-08
Product Quantity30,576 units
Reason for Recall
Risk of internal blood leaks affecting the hemodialyzers.
Firm Action
Fresenius North America notified consignees on 3/6/12 by recall notification letter titled:Urgent FMCNA Optiflux F160NRe Hemodialyzer Recall, by certified mail with return receipt. The letter identified the affected product and described the reason for the recall. Customers were instructed to examine their stock immediately to determine whether they have any of the affected lot on hand. If customers have the affected lot, they have been instructed to immediately discontinue use and place all unused units in a secure area for return to Fresenius Medical Care North America. A Reply Response from is to be completed and returned. Customers have been instructed to contact their Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product. Contact 1-800-323-5188.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.