Baxter Healthcare Corporation: Medical Device Recall in 2022 - (Recall #: Z-1144-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Effluent Sample Bag

Product Classification:

Class II

Date Initiated: April 21, 2022

Date Posted: June 8, 2022

Recall Number: Z-1144-2022

Event ID: 90032

Reason for Recall:

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Status: Ongoing

Product Quantity: 78 units

Code Information:

Product code: R5C4476; UDI: 00085412008738; Lot Number: H18E25030 (exp. date: 04/30/2023), Lot Number: H19D12097(exp. date: 03/31/2024), Lot Number: H19K14040 (exp. date: 10/31/2024),Lot Number: H20B19101 (exp. date: 01/31/2025),Lot Number: H20F17064 (exp. date: 05/31/2025),Lot Number: H20I28073 (exp. date: 08/31/2025),Lot Number: H21D01054 (exp. date: 03/31/2026),Lot Number: H21I24030 (exp. date: 08/31/2026), Lot Number: H21J13040 (exp. date:09/30/2026)

Distribution Pattern:

US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.

Voluntary or Mandated:

Voluntary: Firm initiated