The Recall Desk
Agency classClass IIOur severity: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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units
78

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.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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