Surepulse Medical recalled a component of its newborn heart rate monitor on January 20, 2023. The recall affects the VS Cap Medium REF: SP-161-A1 due to incorrect sizing information on the label. This issue poses a high risk to patients and healthcare providers using the device.
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 Medium is a component of the VS Newborn Heart Rate Monitor, designed for use in neonatal care settings. Healthcare providers purchase this device to monitor vital signs in newborns accurately.
The product labeling contains incorrect sizing information, which can lead to improper use and inaccurate heart rate monitoring. This mislabeling could compromise patient safety and care quality.
This recall is not part of a broader industry pattern.
Consumers must stop using this component, which may disrupt medical services for newborns. The recall indicates a potential risk to patient safety, emphasizing the importance of accurate medical device labeling.
The REF number is usually found on the product packaging or the device itself, typically near the barcode or on the label.
Expect a response from Surepulse Medical within 4-6 weeks regarding refund or replacement processes.
Keep records of the purchase, including receipts, and document any correspondence regarding the recall.
The recalled product is the Surepulse VS Cap Medium, REF: SP-161-A1, which is part of the VS Newborn Heart Rate Monitor. This device was distributed worldwide, including in Connecticut and Texas, as well as the United Kingdom, Netherlands, and United Arab Emirates.
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