The Recall Desk
ModerateFDA (Devices)·Z-0731-2016·Announced 2016-02-10

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.

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: 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)
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.

Same manufacturer · Baxter Corporation Englewood

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