Surepulse Medical recalled its VS Cap Large component for the newborn heart rate monitor on January 20, 2023. The recall addresses an incorrect sizing guide that could affect patient safety. This recall impacts distribution in the US and several countries including the UK and UAE.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SUREPULSE MEDICAL LTD or your healthcare provider for instructions. Notification method: N/A
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The Surepulse VS Cap Large is a component of the VS Newborn Heart Rate Monitor, used to measure heart rates in newborns. This product is critical in neonatal care settings for monitoring vital signs.
The recall concerns an incorrect sizing guide printed on the product label, which can lead to improper application of the cap, potentially affecting monitoring accuracy and patient safety.
This recall is not part of a broader industry pattern.
Consumers must stop using the product immediately, potentially disrupting neonatal monitoring processes in healthcare facilities.
Look for the model and lot numbers on the product packaging or the device itself, usually located on the label or instruction manual.
Expect a refund or replacement processing timeline of approximately 4-8 weeks, depending on manufacturer response.
Keep all receipts, correspondence regarding the recall, and photos of the product as documentation.
The recalled product is the VS Cap Large (REF: SP-162-A1), a component of the VS Newborn Heart Rate Monitor. Model DI Number: 05060550650037 with various lot numbers was distributed worldwide.
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