Class 2 Device Recall MEDICOM SAFEMASK

• Date Initiated by Firm: October 11, 2019
• Create Date: November 19, 2019
• Recall Status: Terminated on September 14, 2021
• Recall Number: Z-0494-2020
• Recall Event ID: 84118
• 510(K)Number: K051291
• Product Classification: Mask, surgical - Product Code FXX
• Product: MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
• Code Information: Lot 1917
• Recalling Firm/ Manufacturer: AMD Medicom Inc.; 1200 55e Ave; Lachine Canada
• For Additional Information Contact: Stephanie Peika ; 514-443-1345
• Manufacturer Reason for Recall: 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.
• FDA Determined 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-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: AMO Medicom Inc. 6054 Shook Road, Suite 200 Lockbourne, OH USA 43137 ATTN: Recall You may use the following courier information: UPS Account# V28W12
• Quantity in Commerce: 756 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FXX