Cook Incorporated is recalling approximately 7,990 units of various medical devices, including Flexor Check-Flo Introducers, Ring Transjugular Intrahepatic Access Sets, and Rüsch-Uchida Transjugular Liver Access Sets. Cook Medical identified that these devices may have been manufactured out of specification, which means they could have been cut to incorrect lengths, not properly trimmed, or not inspected correctly during the manufacturing process. These products are intended for use in specialized diagnostic and interventional procedures, such as liver access.
Impacted products that are cut to the incorrect length or improperly trimmed can lead to procedural complications or internal tissue damage during medical interventions. This manufacturing defect poses a risk to patient safety when clinicians use these incorrectly specified sets for transjugular or other guided medical procedures.
Introducers and Guiding Sheaths incorporate a Flexor shaft with a hemostasis valve and one or more dilators.
Intended for transjugular liver access in diagnostic and interventional procedures.
Intended for transjugular liver access in diagnostic and interventional procedures.
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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