Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
FDA Recall Z-0658-2019 · Posted None
Advertisement
Recalling FirmFresenius Medical Care Renal Therapies Group, LLC
Recall StatusTerminated
Product CodeKDI
Date Initiated2018-11-05
Date Terminated2023-04-17
Product Quantity9,097 cs x 12 units each
Reason for Recall
Potential for external blood leaks from the dialyzer header
Firm Action
On November 6, 2018, Fresenius Medical Care issued URGENT MEDICAL DEVICE RECALL notices to customers. Customers were advised to take the following actions:
1. Check your inventory for the affected lot numbers.
2. If found, discontinue use of these lots.
3. Please all affected units in a secure, segregated area.
4. Contact Stericycle at 1-888-731-7986 for instructions on how to return the recalled product or if replacement product is needed right away. (Refer to EVENT # 6273).
5. Complete and return the Reply Form.
Customers with questions may contact Medical Information and Communications at 855-616-2309 or thru the website www.fresenius-medinfo.com.
Root Cause
Other
Distribution Pattern
US Nationwide
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.
Advertisement