FDA Device recall Z-0343-2023
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
- FDA Device
- Class II
- ongoing
- Published 2022-12-07
On 2022-12-07 the FDA classified a Class II recall of Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 by Owens And Minor Distribution, citing potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0343-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-31 |
| Published | 2022-12-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Owens And Minor Distribution |
| Distribution | IL, IN, WV |
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
Identifiers
| code_info | UDI-DI: 10680651417340 Lot Number: AH1215T51 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2016-12-28 · Owens And Minor Distribution - MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent pa…
FDA Device · Class II · 2016-02-10 · Owens And Minor Distribution - MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent pa…
FDA Device · Class II · 2016-02-10 · Owens And Minor Distribution - MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent pa…
FDA Device · Class II · 2016-02-10 · Owens And Minor Distribution
All Owens And Minor Distribution recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0343-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.