Recall Z-1945-2014 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corp.
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
| Date | Jun 30, 2014 (initiated Jul 8, 2013) |
| Status | Terminated |
| Reason | the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging. |
| Root cause | Packaging change control |
| Action | An Urgent Product Recall notification was mailed via U.S.P.S. first-class mail to facilities, (dialysis centers and distributors) on July 8, 2013 and mailed by first-class mail to home patients on July 11, 2013. |
| Quantity | 20,940 units |
| Distribution | Distributed in the states of AR, TN MO, KS, TX, MS, and AL. |
| 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 |