FDA Device recall Z-1213-2023
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P
- FDA Device
- Class II
- ongoing
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1213-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-01 |
| Published | 2023-03-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
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.
Identifiers
| code_info | UDI/DI 00085412007694, Lot numbers: GD912051, exp 31-Mar-2024; GD912068, exp 30-Apr-2024; GD912099, exp 30-Apr-2024; G…UDI/DI 00085412007694, Lot numbers: GD912051, exp 31-Mar-2024; GD912068, exp 30-Apr-2024; GD912099, exp 30-Apr-2024; GD912112, exp 30-Apr-2024; GD912143, exp 30-Apr-2024; GD912204, exp 31-May-2024. Expansion on 05/10/2023: Product Code 5C4466P with all lots numbers manufactured prior to 09/30/2022. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1213-2023%22
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