Surepulse Medical recalled the VS Cap Small component of its newborn heart rate monitor on January 20, 2023. The recall stems from incorrect sizing information provided on the product label. This defect poses a significant risk to patient safety.
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 Small is a component of a newborn heart rate monitor used for monitoring infant health. Healthcare providers and parents buy this product to ensure accurate heart rate readings for newborns during medical assessments.
The hazard arises from an incorrect sizing guide on the product label, which could result in improper fitting and usage. This can lead to inaccurate readings, potentially compromising the health and safety of infants.
This recall is not part of a broader industry pattern.
Consumers may face inconvenience as they need to discontinue use of the device and seek replacements. The potential health risks underscore the urgency of addressing the sizing error.
Look for the model number and DI number on the product packaging or device label.
Expect a refund or replacement processing time of approximately 4-6 weeks.
Keep copies of your purchase receipt, correspondence with the manufacturer, and any documented medical recommendations.
The recalled product is the Surepulse VS Cap Small, reference number SP-160-A1. It has been distributed worldwide, including nationwide in the United States, specifically in Connecticut and Texas. The distribution also extends to the United Kingdom, Netherlands, and the United Arab Emirates.
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