FDAFDA · Food and drugs·Recall number Z-2150-2012
Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.
Published August 15, 2012 · Recall initiated: July 6, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Battery may become hot and leak
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- FMS, Finapres Medical Systems BV
- Distributor
- US Nationwide Distribution - including the states of: OH and NY
- Lot
- Serial Numbers: 12 02 006, 12 02 008, 12 02 013
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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