Recall Z-1147-2024

Reason for recall

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

FDA-determined cause: Under Investigation by firm

Action taken

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 above-mentioned lot numbers in your inventory, within three (3) working days. In addition, please contact your affected customer base, advise them of the recall and provide them with a copy of this letter. You should insert your contact information, email and fax numbers in the Acknowledgement Form and request that they return the Acknowledgment Form to you. Please have them return any unused inventory to you for reconciliation. Once you have received all inventory from your customers, please contact Medicom customer service at 1-800-308-6589 or claims@medicom.ca to receive a Sales Return Order number to identify your shipment of returns. Please return all units of the affected lots (unsold inventory and returns) to: AMD Medicom Inc. 6054 Shook Road, Suite 200 Lockbourne, OH USA 43137 ATTN: Recall. You may use the following courier information: UPS Account# 1149-6837-4.