American Contract Systems Inc recalls CRANI PACK

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.

CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1406-2025
• FDA device classification · OJGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4525The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find American Contract Systems IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.