TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
This recall is currently active, issued July 5, 2024. It was issued by American Contract Systems Inc.
- Company
- American Contract Systems Inc
- Recall Initiated
- May 15, 2024
- Posted
- July 5, 2024
- Recall Number
- Z-2305-2024
- Quantity
- 393 units
- Firm Location
- Tiffin, OH
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI-DI: 00191072171726 LOT#"s: 640231 973241 742231 934241
Root Cause
Under Investigation by firm
Action Taken
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.