FDAFDA · Food and drugs·Recall number Z-1716-2015
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Published June 17, 2015 · Recall initiated: April 27, 2015
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
Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain.
- Lot
- All lot numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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