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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius Crit Line

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  Class 2 Device Recall Fresenius Crit Line see related information
Date Initiated by Firm December 19, 2014
Date Posted February 03, 2015
Recall Status1 Terminated 3 on February 18, 2021
Recall Number Z-1047-2015
Recall Event ID 70288
510(K)Number K022536  
Product Classification Accessories, blood circuit, hemodialysis - Product Code KOC
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.
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
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-662-1237
Manufacturer Reason
for Recall		 Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KOC and Original Applicant = FRESENIUS MEDICAL CARE
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