Recall archive / FDA device enforcement
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 — FDA record Z-0343-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 31, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
- Reason
- Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
- Classification
- Class II
- Recalling firm
- Owens & Minor Distribution, Inc.
- Quantity
- 72 cases (2160 pouches)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0343-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 10680651417340 Lot Number: AH1215T51 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
IL, IN, WV
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 7, 2022
- Recall initiation date
- Oct 31, 2022
- Center classification date
- Nov 30, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.