FDA Medical devices recall ·
CRANI PACK, Model recall
- Recall number
- Z-1406-2025
- Date
- (initiated February 4, 2025)
- Company / brand
- American Contract Systems Inc
85 Shaffer Park Dr, Tiffin, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 91 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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
Distribution
US: MI
States: Michigan
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1406-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.