Maquet Cardiopulmonary Gmbh has voluntarily recalled 7,754 units of the Sprinter Cart and Sprinter Cart XL Infusion Pole, which are components used to hold two 2-kilogram infusion bags. The recall was initiated because the device does not comply with the labeling requirements of international safety standard IEC 60601-1. No incidents or injuries have been reported to date, and the manufacturer notified customers of the issue via a letter.
Missing or incorrect safety labeling may lead to the equipment being used outside of its intended safety limits, potentially resulting in mechanical failure or instability of the infusion pole during patient care.
Component used to hold 2 x 2 kg infusion bags; non-compliant with labeling requirements of IEC 60601-1.
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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