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 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.
The recall stems from a labeling error that provides incorrect sizing information for the cap component. Incorrect sizing could lead to inaccurate readings or improper use, posing potential health risks for newborns.
There are no specific incidents or injuries reported associated with this recall. However, the high hazard classification indicates a serious risk if the device is used with incorrect sizing.
Patients and healthcare providers must stop using the VS Cap Medium immediately. Follow recall instructions provided by Surepulse Medical or contact your healthcare provider for further guidance.
For more information, contact Surepulse Medical at their official website. For any urgent inquiries, reach out to your healthcare provider.
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