Wilson-Cook Medical Inc. is recalling approximately 4,605 units of the Cook Medical Hemo-7 and Hemo-10 Hemospray Endoscopic Hemostat devices. These medical devices, used to stop gastrointestinal bleeding, were manufactured using raw materials that do not meet quality specifications. Consumers and healthcare providers should be aware that using a device made with non-standard materials could impact the device's performance or safety during surgical procedures. If you have any of the affected lots, contact your healthcare provider or the manufacturer immediately for guidance.
The use of nonconforming raw materials in the manufacturing process may lead to device failure or unpredictable performance during endoscopic procedures, potentially failing to control bleeding or causing unintended patient injury. No specific injuries have been reported in the current data, but the material defect poses a moderate risk to patients undergoing treatment for gastrointestinal bleeding.
Contact healthcare provider or manufacturer for further instructions
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.
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Sources: FDA iRES · Raw API Response
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