SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Extra Large REF: SP-163-A1 component of V
Recalled Product
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Hazard / Issue
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: DI Number: 05060550650044/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
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