Aero Blue Performance Surgical Gown recalled over sterility concerns
- Recall date
- October 31, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Owens & Minor Distribution, Inc. recalls Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
- Recall number
- Z-0343-2023
- FDA classification
- Class II
- Brand / firm
- Owens & Minor Distribution, Inc.
- Sold / distributed
- IL, IN, WV
Why it was recalled
Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
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