Cook Medical is recalling 188 units of Check-Flo Performer Introducers because they may contain the wrong size introducer sheath. The recall involves specific lots of the 10.0Fr and 14.0Fr models distributed globally to hospitals and medical suppliers. Using an incorrectly sized sheath during a procedure could lead to clinical complications or delays, though no injuries have been reported to date.
The incorrectly sized sheath may not function as intended during medical procedures, potentially causing difficulties in vessel access or delays while a replacement is found. No incidents or injuries have been reported.
Recall Number: Z-1786-2025
Recall Number: Z-1787-2025
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.
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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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