SUREPULSE MEDICAL LTD: Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

Hazard

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

Details from the source

Reason for recall: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. 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. Quantity: N/A Lot/code info: DI Number: 05060550650037/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

UPC codes

05060550650037

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.