Recall Z-0920-2014 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.
| Date | Feb 3, 2014 (initiated Dec 17, 2013) |
| Status | Terminated |
| Reason | Bicarbonate Jug Adapter distributed prior to 510(k) approval |
| Root cause | No Marketing Application |
| Action | Fresenius notified customers by telephone and Formal notification on 12/17/13 via the Urgent Bicarbonate Jug Adapter Recall letter sent certified mail with signature confirmation and fax-back form. Customers were instructed to examine their stock immediately to determine whether they have any of the affected parts on hand. If customers have the affected parts, they are instructed to discontinue use and place all Bicarbonate Jug Adapters in a secure area for return to Fresenius Medical Care Renal Therapies Group, LLC (FMC-RTG). Customers instructed to contact their Fresenius Medical Care Techn |
| Quantity | 703 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.