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
- 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
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.
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