Windstone Medical Packaging, Inc. recalls AMS 4674 Custom Pack. For use in a general clinical procedure.
- Recall date
- November 2, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0376-2016
- FDA classification
- Class II
- Brand / firm
- Windstone Medical Packaging, Inc.
- Sold / distributed
- Distributed in AL and VA.
Why it was recalled
AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
AMS 4674 Custom Pack. For use in a general clinical procedure.
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