Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1047-2015)

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:

Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.

Product Classification:

Class II

Date Initiated: December 19, 2014

Date Posted: February 11, 2015

Recall Number: Z-1047-2015

Event ID: 70288

Reason for Recall:

Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope

Status: Terminated

Product Quantity: 35 units

Code Information:

Serial Numbers: 1C31M140038 1C31M140040 1C31M140041 1C31M140042 1C31M140033 1C31M140034 1C31M140035 1C31M140030 1C31M140075 1C31M140031 1C31M140027 1C31M140054 1C31M140057 1C31M140060 1C31M140039 1C31M140056 1C32M140005, 1C32M140059, 1C32M140058, 1C32M140014, 1C32M140013, 1C32M140004, 1C32M140012, 1C32M140011, 1C32M140009, 1C32M140008, 1C32M140003, 1C32M140007, 1C32M140006, 1C32M140023, 1C32M140021, 1C32M140022, 1C32M140020, 1C31M140073, 1C31M140050

Distribution Pattern:

CT, NY

Voluntary or Mandated:

Voluntary: Firm initiated