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U.S. Department of Health and Human Services

Class 2 Device Recall Henry Schein Criterion

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  Class 2 Device Recall Henry Schein Criterion see related information
Date Initiated by Firm December 21, 2023
Date Posted February 16, 2024
Recall Status1 Open3, Classified
Recall Number Z-1146-2024
Recall Event ID 93818
510(K)Number K051291  
Product Classification Mask, surgical - Product Code FXX
Product HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Code Information Item Code: 570-2448; UDI DI: 10304040142520; Lot #s: 2337, 2338, 2342, 2343, 2344;
Recalling Firm/
Manufacturer		 AMD Medicom Inc.
2555 Ch de L'Aviation
Montreal Canada
Manufacturer 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 2		 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 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.
Quantity in Commerce 720 cases (10 boxes/case and 50 masks/box)
Distribution US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FXX and Original Applicant = A.R. MEDICOM, INC.
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