Recall Z-0843-2011 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Fresenius Medical Care Holdings, Inc.
Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9
| Date | Jan 10, 2011 (initiated Nov 19, 2010) |
| Status | Terminated |
| Reason | Hemodialysis Blood tubing Sets may develop kinking of the arterial line. |
| Root cause | Device Design |
| Action | Fresenius Medical issued recall notification dated 11/19/10, "URGENT RECALL FMCNA Combiset BVM Hemodialysis Blood Tubing Sets (Part Numbers 03-2695-9 and 03-27957)", by certified mail with return receipt. Customers have been instructed to check their stock immediately to determine if they have any affected lots on hand. If customers have the affected lots, they have been instructed to discontinue use immediately and place the product in a secure segregated area for return to Fresenius Medical Care North America. Customers have been instructed to contact Fresenius Medical Care Customer Service |
| Quantity | 190,080 units (7920 cases x 24 units) |
| Distribution | Distribution Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962081 | COMBILINES HEMODIALYSIS BLOOD TUBING SET National Medical Care, Medical Products Div., Inc., Nov 1, 1996 |