Surepulse Medical recalled the Extra Large VS Cap component of its newborn heart rate monitor on January 20, 2023. The recall followed reports of incorrect sizing information that could impact device use. This recall affects distribution in the U.S., the U.K., the Netherlands, and the United Arab Emirates.
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 is a component of the VS Newborn Heart Rate Monitor, used primarily in medical settings for monitoring infant heart rates. Parents and healthcare providers utilize this device to ensure the health and well-being of newborns.
The recall stems from a labeling error that provides incorrect sizing information for the cap. This may lead to improper fitting, potentially compromising the device's ability to monitor heart rates accurately.
This recall is not part of a broader industry pattern.
Consumers may face inconvenience in ensuring proper heart rate monitoring for their newborns. Immediate action is required to prevent any potential misuse of the device.
Check the packaging or the device itself for the model and lot numbers, typically found on a label.
Expect a refund or replacement processing timeline of approximately 4-6 weeks.
Keep records of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.
The recalled product is the Extra Large VS Cap, REF: SP-163-A1, part of the VS Newborn Heart Rate Monitor. The specific model numbers include DI Number: 05060550650044 along with various lot numbers from 13816 to 13840. The product was distributed worldwide, primarily in Connecticut and Texas.
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