Medical device recalls Moderate risk

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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