Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
- Company
- Owens & Minor Distribution, Inc.
- Recall Initiated
- October 31, 2022
- Posted
- December 6, 2022
- Recall Number
- Z-0343-2023
- Quantity
- 72 cases (2160 pouches)
- Firm Location
- Mechanicsville, VA
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
IL, IN, WV
Lot / Code Info
UDI-DI: 10680651417340 Lot Number: AH1215T51
Root Cause
Under Investigation by firm
Action Taken
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 OMRA_RECALLS@owens-minor.com as soon as possible even if you have no current product inventory. If you have any questions, please email Caitlin Senter @ OMRA_RECALLS@owens-minor.com using the Event # FCA-2022-009 in the header of the response. This will ensure prompt response by the O&M Halyard, Inc, team.