Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CRANI PACK Recalled by American Contract Systems Inc Due to During an internal investigation, ACS was unable to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact American Contract Systems Inc directly.
Affected Products
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Quantity: 91 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 1 state: MI
About American Contract Systems Inc
American Contract Systems Inc has 81 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report