FDA-Device2022-12-07Class II
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Owens & Minor Distribution, Inc.
Hazard
Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
Sold states
IL, IN, WV
Affected count
72 cases (2160 pouches)
Manufactured in
9120 Lockwood Blvd, Mechanicsville, VA, United States
Products
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0343-2023Don't want to check this manually?
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