Recall Z-1269-2015 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corp.
MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
| Date | Mar 13, 2015 (initiated Jan 22, 2015) |
| Status | Completed |
| Reason | Product may have separating or protruding sponges |
| Root cause | Under Investigation by firm |
| Action | Baxter sent an Urgent Product Recall letter dated January 22, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Baxter is requesting that you take the following actions: 1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product package or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Center for Service can be reached at 888-229-0001, Monday through Friday, between the hours |
| Quantity | 4,391,520 units |
| Distribution | Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain. |
| 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 |