Recall Z-1213-2023 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Baxter Healthcare Corporation
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
| Date | Mar 3, 2023 (initiated Feb 1, 2023) |
| Status | Open, Classified |
| Reason | MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant. |
| Root cause | Process control |
| Action | Baxter Healthcare initiated the recall by issuing an Urgent Medical Device Recall notice to its consignees by letter on 02/01/2023. The notice requested the following from customers: 1. Check your stock and set aside all product with the affected lot numbers. 2. Contact Baxter HomeCare Services to arrange for return of impacted product and for ordering replacement product. 3. If all of your product is impacted by this recall and you are unable to get unaffected lot numbers, resulting in a significant delay in therapy, please follow the below steps: a. Contact your clinic for clinical guid |
| Quantity | 33,866,400 units |
| Distribution | US Nationwide distribution and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution Baxter Healthcare Corporation, Oct 29, 2015 |