Medtronic Perfusion Systems has recalled 85,516 units of various medical devices, including Arterial Cannulae, Venous Cannulae, and Suction Tubes, due to the potential for unsealed sterile packaging. These devices are used during surgical procedures to move blood and other fluids, and if the sterile seal is compromised, the device may no longer be sterile. This defect was discovered during internal quality checks and involves various models such as the DLP Curved Metal Tip Arterial Cannula and the MC2 Two Stage Venous Cannula manufactured in the United States. Consumers should check their inventory against the extensive list of affected model and lot numbers to ensure non-sterile equipment is not used in clinical settings.
An unsealed sterile pouch can allow bacteria and other contaminants to enter the device packaging, compromising its sterility. If these non-sterile devices are used during surgery, they pose a significant risk of causing serious infections or sepsis in patients.
Contact healthcare provider or manufacturer
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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