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 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.
The recall was issued due to a labeling error that contains an incorrect sizing guide for the cap. This mislabeling can lead to improper use and potential harm to newborn patients.
No specific incidents or injuries have been reported in relation to this recall. However, the high hazard classification indicates serious risk.
Stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact Surepulse Medical or your healthcare provider for further instructions.
For more details, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1359-2026.
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