Z-1406-2025Class II

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

Name: Z-1406-2025 CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit
Creator: American Contract Systems Inc
Published: 2025-02-04
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2025-02-04 / Open, Classified / root cause: design

FDA source

American Contract Systems Inc began a recall of CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit on 2025-02-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1406-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-04
Posted: 2025-03-20
Recalling firm: American Contract Systems, Inc.
Product: CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Product code: OJG Neurological Tray
Reason for recall: 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 tag: design
FDA 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 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].
Quantity in commerce: 91 units
Distribution: US: MI
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1406-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1406-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-20

Product code OJG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)