Z-1047-2015Class II

Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time...

Name: Z-1047-2015 Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2014-12-19
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2014-12-19 / Terminated / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of 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... on 2014-12-19. FDA classified it as Class II and gives the reason as "Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1047-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-02-03
Terminated: 2021-02-18
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
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.
Product code: KOC Accessories, Blood Circuit, Hemodialysis
Reason for recall: Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
Root cause tag: design
FDA root cause: Device Design
Action: FMCRTG, LLC representatives contacted Clinics on 12/19/14 by visit/telephone phone) and removed all CLiC units.
Quantity in commerce: 35 units
Distribution: CT, NY
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1047-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1047-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-03

Product code KOC

K022536Class II\Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving ConnectorFresenius Medical Care / cleared 2002-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)