Recall Z-1406-2025 ยท OJG Neurological Tray
American Contract Systems Inc
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
| Date | Mar 20, 2025 (initiated Feb 4, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 eac |
| Quantity | 91 units |
| Distribution | US: MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.