Z-1213-2023 Class II Ongoing
FDA device recall Z-1213-2023 was initiated by Baxter Healthcare Corporation on February 1, 2023 and is designated Class II. Reason for recall: 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, res… The recall status is ongoing. Affected quantity: 33,866,400 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2023
- Initiation Date
- February 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,866,400 units
Product Description
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution and Canada.
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.