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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 Freseniussee related information
Date Initiated by FirmApril 27, 2015
Date PostedJune 05, 2015
Recall Status1 Terminated 3 on February 18, 2021
Recall NumberZ-1716-2015
Recall Event ID 71093
510(K)NumberK935958 
Product Classification Accessories, blood circuit, hemodialysis - Product Code KOC
ProductCRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Code Information All lot numbers
FEI Number 3001451489
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information ContactFMCRTG, 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
ActionFresenius 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 Commerce22,640,288
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = KOC
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