PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 17, 2015 Initiated: April 27, 2015 #Z-1716-2015

Product Description

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

Reason for Recall

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

Details

Units Affected
22,640,288
Distribution
Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 22,640,288.
Why was this product recalled?
Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber
Which agency issued this recall?
This recall was issued by the FDA Devices on June 17, 2015. Severity: Moderate. Recall number: Z-1716-2015.