Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Recall
- Recall Number
- Z-0343-2023
- Event Number
- 91122
- Firm
- Owens & Minor Distribution, Inc.
- FEI Number
- 3003753847
- Product Code
- FYA
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- October 31, 2022
- Posted
- December 6, 2022
- Address
- 9120 Lockwood Blvd, Mechanicsville, VA, 23116-2015
Description
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
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-users are appropriately notified of this recall notification. 5. RETURN the completed Recall Response Form and Certificate of Destruction Form to [email protected] as soon as possible even if you have no current product inventory. If you have any questions, please email Caitlin Senter @ [email protected] using the Event # FCA-2022-009 in the header of the response. This will ensure prompt response by the O&M Halyard, Inc, team.
IL, IN, WV
72 cases (2160 pouches)