Windstone Medical Packaging, Inc. recalls AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
- Recall date
- October 24, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0069-2018
- FDA classification
- Class II
- Brand / firm
- Windstone Medical Packaging, Inc.
- Sold / distributed
- US Distribution to the state of : SC
Why it was recalled
Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
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, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
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