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Terminated

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.

FDA Recall Z-1047-2015 · Posted 2015-02-03

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKOC
Date Initiated2014-12-19
Date Terminated2021-02-18
Product Quantity35 units

Reason for Recall

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

Firm Action

FMCRTG, LLC representatives contacted Clinics on 12/19/14 by visit/telephone phone) and removed all CLiC units.

Root Cause

Device Design

Distribution Pattern

CT, NY

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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