Recall Z-2074-2014 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.
| Date | Jul 17, 2014 (initiated Jun 17, 2014) |
| Status | Terminated |
| Reason | Inadequate iodine and packaging related defects. |
| Root cause | Packaging process control |
| Action | The firm notified their direct consignees on 06/17/2014 by letter requesting customers to locate and remove all affected product from their facility, and contact Baxter Healthcare Center for Service to arrange for return and credit. |
| Quantity | 585,360 units |
| Distribution | Distributed USA (nationwide) and Canada. |
| 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 |