Crani Pack (American Contract) – sterilization uncertainty (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.

Recommended Action

Per FDA guidance

Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION notice to its consignees on 02/01/2025 via email. The notice explained the issue, risk to health, and requested the following: ACTIONS TO TAKE: " Discontinue use of the Codman Integrated Bipolar Cord and Tubing Set (Manufacturer's Item Number COD9190002RPB, ACS Item Number 347473). " Add warning labels to affected kits which contain the component to ensure the component is 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 received 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. You are also responsible for the reconciliation of these customers. Please do not have your customers respond directly to ACS. " Complete the attached Recall Response Form and return as soon as possible. Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com.

Distribution

As reported by FDA

MI