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U.S. Department of Health and Human Services

Class 2 Device Recall American Contract Systems (ACS)

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  Class 2 Device Recall American Contract Systems (ACS) see related information
Date Initiated by Firm May 15, 2024
Date Posted July 05, 2024
Recall Status1 Open3, Classified
Recall Number Z-2277-2024
Recall Event ID 94765
Product Classification Orthopedic tray - Product Code OJH
Product LOWER EXTREMITY - 247542- Procedure tray
Catalog Number: BFLE56X
Code Information UDI-DI: 00191072214553 LOT#"s: 943241
Recalling Firm/
American Contract Systems Inc
85 Shaffer Park Dr
Tiffin OH 44883-9290
For Additional Information Contact SAME as Above
Manufacturer Reason
for Recall
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
FDA Determined
Cause 2
Under Investigation by firm
Action American Contract Systems issued Urgent Voluntary Recall Letter (FA-2024-018) via email on 5/15/24 to Distributors. Distributors to notify end-users. Letter states reason for recall, health risk and action to take: Immediately discontinue use of the cast padding component (DISCARD ITEM 4927009046-CAST PADDING, 6" Cotton Blend Rayon) included in each kit/tray identified in ATTACHMENT 1. Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. "Add warning labels to all kits/cases impacted: A labeling template is enclosed for printing warning labels which should be affixed to all affected product in inventory. This label should be affixed to each affected kit and case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing labeling. "Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. "Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. "Complete the enclosed Response Form and return as soon as possible. "If credit is requested, please send an email to quality@owens-minor.com.
Quantity in Commerce 48 units
Distribution US Nationwide distribution.
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.