Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1716-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 27, 2015

Date Posted: June 17, 2015

Recall Number: Z-1716-2015

Event ID: 71093

Reason for Recall:

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

Status: Terminated

Product Quantity: 22,640,288

Code Information:

All lot numbers

Distribution Pattern:

Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated