AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
- Company
- American Contract Systems Inc
- Recall Initiated
- July 14, 2025
- Posted
- August 28, 2025
- Recall Number
- Z-2471-2025
- Quantity
- 50 units
- Firm Location
- Tiffin, OH
Reason for Recall
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Distribution
US distribution to states of: IL and LA
Lot / Code Info
1) MODEL/ITEM NUMBER GRRB10E: UDI/DI 00191072236371, Kit Lot Numbers: 42-8157011, 42-8126811; 2) MODEL/ITEM NUMBER SPVH62P: UDI/DI 00191072238771, Kit Lot Numbers: 12-7322911, 12-7384911.
Root Cause
Under Investigation by firm
Action Taken
Owens & Minor issued an "URGENT: MEDICAL DEVICE CORRECTION" notice to its consignees on 07/15/2025 via email. The notice explained the problem, potential risk to health, and requested the following: ACTIONS TO TAKE: " Discontinue use of all affected components. " Add warning labels to affected procedure trays to ensure the components are discarded. A labeling template is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be applied to each affected procedure tray and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. o Customers (end-users): If you receive a product from a distributor, please contact the distributor or your sales representative with any questions you may have. o Distributors: If any of the affected procedure trays identified above were further distributed, please ensure all end-users are appropriately notified of this product correction and maintain records of effectiveness for your consignees. " Complete the attached Recall Response Form and return as soon as possible to GM-OMRA_RECALLS@owens-minor.com. Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com. If you have any questions, contact the Manager, Regulatory Affairs at 470-280-4277 or email to: GM-OMRA_RECALLS@owens-minor.com.