Recall Z-0495-2020 ยท FXX Mask, Surgical
AMD Medicom Inc.
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
| Date | Oct 11, 2019 |
| Status | Terminated |
| Reason | Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall notification letters dated 10/11/19 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 product code 2040 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 above- |
| Quantity | 112 cases (500 units/case) |
| Distribution | The products were distributed tot he following US states: CA, FL, IA, IN, MD, MI, NV, NY, PA, SC, TN, TX, and WA. The products were distributed to the following foreign countries: Canada. |
| 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 |