CRANI PACK, Model/Catalog Number WECR41D, medical procedure… recallZ-1406-2025 · American Contract Systems Inc · initiated Feb 4, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from American Contract Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-1406-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 4, 2025
- Posted by the FDA
- Mar 20, 2025
- Recalling firm
- American Contract Systems Inc
- Quantity
- 91 units
- Product code
- OJG
- Distribution
- US: MI
Product description
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Code information (models, lots, serial numbers)
Lot Code: UDI: 191072216984, Lot Cocdes: 71-052536, Exp: 10/30/2025; 71-051491, Exp: 07/16/2025; LOT: 71-051609, Exp: 07/30/2025; 71-051767, Exp: 08/14/2025; 71-053065, Exp: 12/10/2025
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ACS WECR41DAmerican Contract Systems, Inc. · Neurological tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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