Recall Z-1684-2021 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Baxter Healthcare Corporation
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
| Date | Apr 14, 2021 |
| Status | Terminated |
| Reason | There is a potential leak between the venous patient connector and patient's hemodialysis access. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Recall communication will be sent to affected customers via USPS, first class mail. Baxter is asking customers to: 1) Locate and remove all affected product from your facility. 2) Contact Baxter Healthcare Center for Service to arrange for return and credit. 3) Complete the enclosed Baxter Customer Reply Form and return it to Baxter by email. |
| Quantity | 17,487 units |
| Distribution | Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070414 | GAMBRO CARTRIDGE BLOOD SETS Gambro Renal Products, Oct 12, 2007 |