Device product
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Z-1213-2023
Product summary
- Event
- Event 91612
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 33,866,400 units
- Official record key
device-enforcement:Z-1213-2023
Official wording
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.
Code information: 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.
Distribution pattern: US Nationwide distribution and Canada.
Derived failure modes
-
Unknown
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.