Recall Z-1146-2024 ยท FXX Mask, Surgical
AMD Medicom Inc.
HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
| Date | Feb 16, 2024 (initiated Dec 21, 2023) |
| Status | Open, Classified |
| Reason | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall notification letters dated 12/21/2023 were sent to customers. AMD Medicom requests that you discontinue distribution/use of and return all products from the catalog/lot number referenced above, for a credit. Our records indicate that you have purchased one or more of the referenced products for re-sale to your customers. You should complete the attached Acknowledgment Form for inventory you have received and/or which is still in stock. AMD Medicom requests that you complete and return the Acknowledgment Form enclosed with this letter, even if you do not have the ab |
| Quantity | 720 cases (10 boxes/case and 50 masks/box) |
| Distribution | US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051291 | NON-STERILE SURGICAL MASK A.R. Medicom, Inc., Sep 20, 2005 |