Baxter Healthcare Corporation: Medical Device Recall in 2023 - (Recall #: Z-1213-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis

Product Classification:

Class II

Date Initiated: February 1, 2023

Date Posted: March 15, 2023

Recall Number: Z-1213-2023

Event ID: 91612

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.

Status: Ongoing

Product Quantity: 33,866,400 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated