Recall Z-0658-2019 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Renal Therapies Group, LLC
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
| Date | Nov 5, 2018 |
| Status | Terminated |
| Reason | Potential for external blood leaks from the dialyzer header |
| Root cause | Other |
| 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 |
| Quantity | 9,097 cs x 12 units each |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |