Physio-Control, Inc. is recalling 245 units of the LIFEPAK 35 ECG cable (REF 11111-000041) because the product was shipped with incorrect Instructions for Use (IFU). The provided instructions do not contain the proper procedures for cleaning and disinfecting the cables. While no injuries have been reported, consumers should contact the manufacturer or their authorized distributor for the correct instructions to ensure the cables are decontaminated properly.
The lack of proper cleaning and disinfection instructions could lead to ineffective decontamination of the medical device between uses. This poses a potential risk of cross-contamination or infection to patients.
Product shipped with incorrect IFU.
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
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