Surepulse Medical recalled its VS Cap Extra Small component of the VS Newborn Heart Rate Monitor on January 20, 2023. The recall affects devices distributed in the US and several other countries due to an incorrect sizing guide. Consumers must stop using the device immediately and follow manufacturer instructions.
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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The Surepulse VS Cap Extra Small is a component of the VS Newborn Heart Rate Monitor. It is used in medical settings to monitor heart rates in newborns, which is critical for patient care.
The hazard arises from an incorrect sizing guide, which could lead to improper application of the heart rate monitor cap. This mislabeling can result in inaccurate heart rate readings, potentially jeopardizing patient safety.
This recall is not part of a broader industry pattern.
Consumers should stop using the device immediately to avoid any risks associated with inaccurate heart rate monitoring.
The model number and lot numbers can typically be found on the packaging or on the device itself.
The timeline for refunds or replacements has not been specified in the recall notice.
Keep records of your purchase, correspondence with the manufacturer, and any documentation related to the recall.
The recalled product is the Surepulse VS Cap Extra Small, REF: SP-159-A1. It was distributed worldwide, including Connecticut and Texas in the US, the United Kingdom, the Netherlands, and the United Arab Emirates.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
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.
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.
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.
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.