Medical device recalls Moderate risk

Baxter Corporation Englewood recalls Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)

Recall date
December 21, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0731-2016
FDA classification
Class II
Brand / firm
Baxter Corporation Englewood
Sold / distributed
Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.

Why it was recalled

All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)

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