FDA-Device2026-02-18Class III

Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor

SUREPULSE MEDICAL LTD

Hazard

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Sold states

Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.

Affected count

N/A

Manufactured in

Medicity D6 Thane Road, N/A, Nottingham, N/A, United Kingdom

Products

Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1357-2026

Original summary

Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. DI Number: 05060550650013/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001 Distribution: Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates. Affected quantity: N/A

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