Recall Z-0343-2023 ยท FYA Gown, Surgical
Owens & Minor Distribution, Inc.
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
| Date | Dec 6, 2022 (initiated Oct 31, 2022) |
| Status | Open, Classified |
| Reason | Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection |
| Root cause | Under Investigation by firm |
| Action | Owens & Minor initiated recall by Voluntary Recall - EVENT # FCA-2022-009 letter dated 10/31/22 via email and Overnight mail. Letter states reason for recall, health risk and action to take: 1. REVIEW your inventory for the affected products. 2. SEGREGATE AND QUARANTINE all product on-hand per the Affected Product table above. 3. DESTROY or DISCARD the product per the facility s standard disposal procedure for surgical gowns. 4. COMMUNICATE this recall to staff to ensure awareness of the product issue. If the affected product identified above was further distributed, please ensure all end-user |
| Quantity | 72 cases (2160 pouches) |
| Distribution | IL, IN, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192362 | Aero Blue Performance Surgical Gowns O&M Halyard, Inc., Dec 13, 2019 |