CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Reported: March 26, 2025 Initiated: February 4, 2025 #Z-1406-2025
Product Description
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
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.
Details
- Recalling Firm
- American Contract Systems Inc
- Units Affected
- 91 units
- Distribution
- US: MI
- Location
- Tiffin, OH
Frequently Asked Questions
What product was recalled? ▼
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.. Recalled by American Contract Systems Inc. Units affected: 91 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1406-2025.
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