Medical device recalls Moderate risk

Fresenius Medical Care Holdings, Inc. recalls CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021

Recall date
April 27, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1716-2015
FDA classification
Class II
Brand / firm
Fresenius Medical Care Holdings, Inc.
Sold / distributed
Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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