The Recall Desk
ModerateFDA (Devices)·Z-1144-2022·Announced 2022-06-08

Baxter Effluent Sample Bags Recalled for Lack of FDA Clearance

Baxter Healthcare recalled 78 Effluent Sample Bags that were distributed without FDA regulatory clearance. The product was distributed in error across eight states.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II device distributed without required regulatory clearance due to distribution error. This is a voluntary precautionary recall with no reported illnesses, injuries, or identified safety defect.

Plain-English summary

Baxter Healthcare Corporation has recalled Effluent Sample Bags because certain product codes do not have FDA regulatory clearance and were distributed in the United States in error.

The recall involves 78 units of product code R5C4476 (UDI 00085412008738) distributed across California, Missouri, Massachusetts, Arizona, Texas, Florida, New York, Maryland, and Ohio. Multiple lot numbers are affected with expiration dates ranging from April 2023 through September 2026.

The recalled product

Product
Effluent Sample Bag
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Peritoneal Dialysis
Hazard
  • lack-of-fda-clearance

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • 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

Distributed nationwide across the United States.

Related recalls

Same category