Baxter RAPIDFILL Syringe Strips Recalled for Shelf Life Packaging Claim
Baxter is recalling RAPIDFILL Syringe Strips because the packaging claims a 12-month shelf life without supporting evidence.
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: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) when no specific injuries or illnesses are reported, as the hazard is primarily related to labeling and shelf-life verification rather than immediate physical danger.
Plain-English summary
Baxter Corporation is recalling all lots of RAPIDFILL Syringe Strips, 10 ml, which are used with the RAPIDFILL Automated Syringe Filler. The recall involves 4,695 units that were distributed nationwide in the United States, as well as in Canada, Sweden, Germany, and the Netherlands.
The recall was initiated because the product lacks evidence supporting the packaging claim for a 12-month shelf life on the released product. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities and distributors should stop using the affected syringe strips and contact Baxter Corporation for further instructions regarding the return or disposal of the product.
The recalled product
- Product
- Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
- Manufacturer
- Baxter Corporation Englewood
- Category
- Medical Device — Syringe Strips
- Hazard
- Affected units
- 4,695
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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