Surepulse Medical Ltd Recalls VS Cap Large Due to Incorrect Labeling Sizing Guide

What Happened

Surepulse Medical Ltd has voluntarily initiated a recall for the Surepulse VS Cap Large. The recall was triggered after it was determined that the product labeling contains an incorrect sizing guide for the cap, which serves as a component of the VS Newborn Heart Rate Monitor. This issue was retroactively reported and has been classified as a Class III recall by the FDA.

Which Products Are Affected

The recall affects the following medical device component:

• Product Name: Surepulse VS Cap Large (component of VS Newborn Heart Rate Monitor)
• Model/REF Number: SP-162-A1
• DI Number: 05060550650037
• Lot Numbers: 13816/00001 through 13840/00001
• Recall Number: Z-1359-2026

Distribution of the affected products occurred nationwide in the United States, specifically within the states of Connecticut (CT) and Texas (TX), as well as internationally in the United Kingdom, Netherlands, and United Arab Emirates.

What You Should Do

Healthcare providers and facilities utilizing the VS Newborn Heart Rate Monitor should check their inventory for the affected lot numbers (13816/00001 through 13840/00001) of the VS Cap Large. Users should be aware that the sizing guide provided on the labeling for these specific lots is incorrect. For further information regarding the return or correction of the labeling, contact Surepulse Medical Ltd at their Nottingham, United Kingdom headquarters.

Why This Matters

This recall is significant as it addresses a labeling error that could lead to the selection of an improperly sized cap for newborn heart rate monitoring. Ensuring accurate sizing information is essential for the proper function and fit of neonatal medical equipment.

Source

Information provided by the U.S. Food and Drug Administration (FDA).