Class 2 Device Recall FLUIDSHIELD 3 N95

• Date Initiated by Firm: August 09, 2023
• Date Posted: September 21, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2626-2023
• Recall Event ID: 92942
• 510(K)Number: K974068
• Product Classification: Respirator, surgical - Product Code MSH
• Product: FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
• Code Information: UDI-DI: 20680651468271; Lot Number AM2164811
• Recalling Firm/ Manufacturer: O&M HALYARD, INC.; 9120 Lockwood Blvd; Mechanicsville VA 23116-2015
• Manufacturer Reason for Recall: One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
• FDA Determined Cause: Under Investigation by firm
• Action: An "URGENT: PRODUCT FIELD ACTION" dated 8/9/23 was sent to customers. The letter described the product, the problem and actions to take. The customers were instructed to do the following: If you received the lot identified above, please review your inventory, and segregate and quarantine all affected product. All other codes and lots of this product are NOT impacted by this Field Action. Customers (end-users): 1. REVIEW your inventory for the affected product code and specific lot number. 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 face masks. 4. COMMUNICATE this Field Action to staff to ensure awareness of it. 5. RETURN the completed Field Action 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. 6. Any adverse events associated with the use of the affected product should be reported to PIQ@hyh.com. 7. If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. If you have any questions, please email Anu Singh @ OMRA_RECALLS@owens-minor.com using the Event # FA-2023-011 in the header of the response. This will ensure prompt response by the O&M Halyard, Inc. team.
• Quantity in Commerce: 41790 masks
• Distribution: US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia
• 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 = MSH