American Contract Systems Inc. (ACS) has recalled 91 CRANI PACK medical procedure kits (Model WECR41D) because an internal component from Codman could not be confirmed as sterile. During an internal investigation, the company found that this component did not meet required sterility standards, meaning it is not suitable for surgical use. Although no injuries or infections have been reported to date, the use of non-sterile equipment during surgery is a significant safety risk.
The use of medical tools that are not sterile can introduce bacteria or other contaminants directly into a patient during surgery, which can lead to life-threatening post-operative infections.
Recall initiated due to inability to confirm Sterility Assurance Level for the CODMAN component.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.