Recall Z-2626-2023 ยท MSH Respirator, Surgical
O&M HALYARD, INC.
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
| Date | Sep 21, 2023 (initiated Aug 9, 2023) |
| Status | Open, Classified |
| Reason | One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user. |
| Root 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 DISCA |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974068 | PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL Tecnol Medical Products, Inc., Dec 22, 1997 |