Recall Z-1047-2015— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1047-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-19

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2014-12-19, terminated 2021-02-18. It names one FDA 510(k) clearance: K022536. Product: 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.. Reason: Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Terminated: 2021-02-18
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K022536 — \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTORFresenius Medical Care·cleared 2002-10-30

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

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.

Reason for recall

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

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