Z-0343-2023 Class II Ongoing
FDA device recall Z-0343-2023 was initiated by Owens & Minor Distribution, Inc. on Oct 31, 2022 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 72 cases (2160 pouches).
Recall details
- Product Type
- Devices
- Report Date
- Dec 7, 2022
- Initiation Date
- Oct 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 cases (2160 pouches)
Product description
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 pattern
IL, IN, WV
Code information
UDI-DI: 10680651417340 Lot Number: AH1215T51
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0343-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026