LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
Recall
- Recall Number
- Z-2277-2024
- Event Number
- 94765
- Firm
- American Contract Systems Inc
- FEI Number
- 3008492337
- Product Code
- OJH
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 15, 2024
- Posted
- July 5, 2024
- Address
- 85 Shaffer Park Dr, Tiffin, OH, 44883-9290
Description
LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
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.
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 [email protected].
US Nationwide distribution.
48 units