Cranial Surgery Procedure Kit Recalled Over Sterility Assurance Failure
American Contract Systems Inc is recalling 91 CRANI PACK cranial procedure kits because a critical component cannot be confirmed to meet sterility requirements, making them unsuitable for surgical use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a potential sterility assurance failure on surgical equipment. No illnesses, injuries, or deaths have been reported. The classification reflects risk-of-harm from inadequate sterilization of surgical instruments without documented patient impact.
Plain-English summary
American Contract Systems Inc is recalling the CRANI PACK, Model WECR41D, a medical procedure kit used in cranial surgery. The recall affects 91 units that were distributed to facilities in Michigan.
During an internal investigation, the manufacturer was unable to confirm that a component within the kit achieved the required Sterility Assurance Level. Because of this uncertainty, the kit cannot be reliably sterilized according to the manufacturer's procedures and is unsuitable for use in surgical applications.
Healthcare facilities that received affected units should immediately discontinue use and contact American Contract Systems Inc for return and replacement instructions. The affected lot codes have expiration dates ranging from July 2025 to December 2025. Patients who may have undergone procedures with these kits should consult their healthcare providers if they have concerns.
The recalled product
- Product
- CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterility-assurance
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
Distributed in 1 state:
- MI
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