FDA-Device2015-06-17Class II

CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021

Fresenius Medical Care Holdings, Inc.
Hazard

Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber

Sold states
Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain.
Affected count
22,640,288
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1716-2015

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