Recall Z-1118-2021 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Baxter Healthcare Corporation
Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
| Date | Dec 30, 2020 |
| Status | Open, Classified |
| Reason | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| Root cause | Under Investigation by firm |
| Action | The firm issued a Safety Alert on 12/30/2020 by mail. The letter explained the problem with photographs, and the hazard involved with using a device with a kinked line. Customers identifying set with kinked tubing may contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Distributor were asked to notify their customers by distributing the letter. |
| Quantity | 7437480 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070414 | GAMBRO CARTRIDGE BLOOD SETS Gambro Renal Products, Oct 12, 2007 |