FDA recall Z-0343-2023

Owens & Minor Distribution, Inc. · Class II · device

Product

Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734

Reason for recall

Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection

Distribution

IL, IN, WV

Key facts

Status
Ongoing
Initiation date
2022-10-31
Report date
2022-12-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mechanicsville, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0343-2023