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U.S. Department of Health and Human Services

Class 2 Device Recall Liberty Cycle Selecter

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  Class 2 Device Recall Liberty Cycle Selecter see related information
Date Initiated by Firm September 12, 2020
Create Date November 07, 2020
Recall Status1 Completed
Recall Number Z-0439-2021
Recall Event ID 86537
510(K)Number K171652  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product Liberty Select Cycler
Software Version 2.9.0
Model Number 180343 and RTLR180343
Code Information All Liberty Select Cyclers with Software Version 2.9.0 Model Number 180343 and RTLR180343
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
For Additional Information Contact Fresenius Medical Care Technical Service
800-227-2572
Manufacturer Reason
for Recall		 The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.
FDA Determined
Cause 2		 Device Design
Action On September 16, 2020, Urgent Medical Device Correction notices and response forms were issued to home therapy nurse managers and patients. Patients using a Liberty Select cycler with software version 2.9.0 are instructed to disable the Flow Alert option. Patients will no longer receive on an-screen Flow Alert message or an audible Flow Alert series of beeps. Instructions for disabling the Flow Alert alarm are included in the notification letter. Patients should continue to use their Liberty Select Cycler for treatment with the Flow Alert option set to "No". Fresenius Medical Care LLC is not requesting the return of the Liberty Select cyclers software version 2.9.0. Replacing the Liberty Select cycler will not resolve this issue. Please complete and return the enclosed Reply Form, indicating receipt and understanding of the communication and actions to take. For additional information, please call 1-855-616-2309 Monday - Friday 8:30 am-5 pm, EST or submit an online request any time at www.fmcna-medinfo.com.
Quantity in Commerce 9,907 devices
Distribution Distributed nationwide throughout the U.S and Puerto Rico. 9,907 devices currently in the field. 361 devices have been deactivated. 4,870 devices are ready to be shipped to customers along with the Urgent Medical Device Correction notice and response form.
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.
510(K) Database 510(K)s with Product Code = FKX and Original Applicant = Fresenius Medical Care Renal Therapies Group, LLC
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