Recall Z-1716-2015— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1716-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-27

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2015-04-27, terminated 2021-02-18. It names one FDA 510(k) clearance: K935958. Product: CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021. Reason: Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-27
Terminated: 2021-02-18
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K935958 — CRIT-LINE BLOOD CHAMBER WITH E-BEAMIn-Line Diagnostics Corp.·cleared 1995-01-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.