Class 2 Device Recall Haylard

• Date Initiated by Firm: October 31, 2022
• Date Posted: December 06, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0343-2023
• Recall Event ID: 91122
• 510(K)Number: K192362
• Product Classification: Gown, surgical - Product Code FYA
• Product: Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
• Code Information: UDI-DI: 10680651417340 Lot Number: AH1215T51
• Recalling Firm/ Manufacturer: Owens & Minor Distribution, Inc.; 9120 Lockwood Blvd; Mechanicsville VA 23116-2015
• For Additional Information Contact: SAME; 804-723-7000
• Manufacturer 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
• FDA Determined 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-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.
• Quantity in Commerce: 72 cases (2160 pouches)
• Distribution: IL, IN, WV
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FYA