SUREPULSE MEDICAL LTD — Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
⚠️ Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 20, 2023
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.
What's affected?
- Product
- Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
- Lot code
- 13816/00001
Additional details
DI Number: 05060550650020/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
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: N/A.
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