Recall Z-1059-2023 ยท FXX Mask, Surgical
Owens & Minor Distribution, Inc.
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
| Date | Feb 3, 2023 (initiated Jan 3, 2023) |
| Status | Open, Classified |
| Reason | Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops. |
| Root cause | Labeling Change Control |
| Action | On January 3, 2023, the firm notified affected distributors via email with a "VOLUNTARY FIELD CORRECTION" letter. Consignees are instructed to immediately stop use of the product, quarantine any stock and destroy all the product using the facility s standard disposal procedure. Consignees are requested to complete and return a Recall FIELD CORRECTION RESPONSE FORM and a Certificate of Destruction. If you have any questions, please email Anu Singh @ OMRA_RECALLS@owens-minor.com using the Event # FCA-2022-012 in the header of the response. |
| Quantity | 73 cases |
| Distribution | US distribution to IL, NC, NY, OH, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131879 | KC 300 SURGICAL MASK Kimberly-Clark Corp., Dec 20, 2013 |