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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius

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  Class 2 Device Recall Fresenius see related information
Date Initiated by Firm April 27, 2015
Date Posted June 05, 2015
Recall Status1 Terminated 3 on February 18, 2021
Recall Number Z-1716-2015
Recall Event ID 71093
510(K)Number K935958  
Product Classification Accessories, blood circuit, hemodialysis - Product Code KOC
Product CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters
Model: CL10021021
Code Information All lot numbers
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact FMCRTG, LLC Customer Service Team:
800-323-5188
Manufacturer Reason
for Recall		 Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber
FDA Determined
Cause 2		 Under Investigation by firm
Action Fresenius LLC North America notified accounts by letter sent certified mail on May 22, 2015, expanding the recall to All lots. Previously recall letters were on April 30, 2015, 2nd notice on May 14, 2015. Users are requested to examine inventory, discontinue use and return product. Contact FMCRTG, LLC Customer Service Team 1-800-323-5188 for instructions. A reply form is included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. Confirmation of delivery will be obtained through the use of registered mail.
Quantity in Commerce 22,640,288
Distribution Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain.
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 = IN-LINE DIAGNOSTICS CORP.
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