Recall Z-1565-2013 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corp.
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.
| Date | Jun 21, 2013 (initiated May 21, 2013) |
| Status | Terminated |
| Reason | leaking pouches |
| Root cause | Packaging change control |
| Action | The firm, Baxter Healthcare Corporation sent an "URGENT PRODUCT RECALL" letter dated May 21, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For general questions regarding this communication, contact The Center for One Baxter at 1-800-422-9837. |
| Quantity | 629,280 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K895631 | DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466 Baxter Healthcare Corp, Jan 29, 1990 |