Medtronic Perfusion Systems is recalling approximately 3,850 units of Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), catalog number REF 402-03. Medtronic staff discovered trace amounts of dried blood on the external carton labels and the Instructions for Use (IFU) in five boxes from a specific production lot. These cartridges are diagnostic tools used to monitor blood clotting times during clinical procedures.
Although the trace amounts of dried blood were found on the outside of the packaging and instructions rather than inside the sterile cartridge, the presence of biological material poses a potential biohazard and cross-contamination risk to healthcare workers handling the boxes.
Quantity: 3,850 units. REF 402-03.
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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Sources: FDA iRES · Raw API Response
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