Baxter Healthcare MiniCap Extended Life PD Transfer Sets Recalled for Regulatory Non-Compliance
Baxter Healthcare is recalling 498 units of MiniCap Extended Life PD Transfer Sets because they were distributed without FDA regulatory clearance. Affected units were distributed in 16 U.S. 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: This is an FDA Class II recall involving regulatory non-compliance due to lack of FDA clearance. No reported illnesses, injuries, or identified safety hazards are mentioned in the source text. The absence of reported incidents supports a Moderate severity rating.
Plain-English summary
Baxter Healthcare Corporation is recalling 498 units of MiniCap Extended Life PD Transfer Sets following distribution without FDA regulatory clearance.
The recalled transfer sets include product codes 5C4482S, R5C4482, R5C4483, and R5C4484, with multiple lot numbers and expiration dates documented by the FDA.
Distribution occurred nationwide across 16 U.S. states: California, Colorado, Delaware, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, and the District of Columbia.
The specific lot numbers and product codes are available through the FDA's recall notice for verification purposes.
The recalled product
- Product
- MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- regulatory-non-compliance
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 (17)
- Product Code 5C4482S
- UDI: 0085412476261
- UDI: 0085412008776
- Lot Number (Expiration Date): H18E18050 (05/18/2023)
- H20K06084 (11/06/2025)
- H20L08070 (12/08/2025)
- H21E07058 (05/07/2026)
- H21F07049 (06/07/2026)
- H21F08070 (06/08/2026)
- H21F28060 (06/28/2026)
- H21K16066 (11/16/2026) Product Code R5C4483
- UDI: 0085412008783
- UDI: 0085412050768
- Lot Number (Expiration Date): H17H03057 (08/03/2022)
- H18G16076 (07/16/2023)
- H19E31052 (05/31/2024)
- H21B16056 (02/16/2026)
Distribution
Distributed nationwide across the United States.
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