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U.S. Department of Health and Human Services

Class 3 Device Recall Liberty Select Cycler

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  Class 3 Device Recall Liberty Select Cycler see related information
Date Initiated by Firm October 24, 2023
Date Posted December 26, 2023
Recall Status1 Open3, Classified
Recall Number Z-0619-2024
Recall Event ID 93579
510(K)Number K222318  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Code Information UDI-DI 00840861102068 Serial Numbers LC002956 LC102178 LC021724 LC107205 LC023197 LC021734 LC017434 LC108957 LC022069 LC103031 LC006834 LC022218 LC017378 LC026229 LC022262 LC104084 LC005140 LC022616 LC019115 LC021388 LC024210 LC108220 LC020906 LC024377 LC023711 LC121383 LC025541 LC118552 LC010607 LC025545 LC015082 LC111682 LC026353 LC114222 LC105047 LC102656 LC113355 LC104022 LC103069 LC115736 LC109288 LC104268 LC016965 LC121349 LC104371 LC105964 LC003341 LC104630 LC016669 LC113929 LC105108 LC020357 LC111447 LC105656 LC003460 LC112030 LC105951 LC107408 LC025450 LC106453 LC109867 LC012490 LC107813 LC108319 LC106079 LC108527 LC106667 LC122086 LC108652 LC110922 LC119859 LC108929 LC022708 LC010574 LC108988 LC113343 LC118563 LC109815 LC000539 LC105216 LC110210 LC108637 LC103326 LC112490 LC103658 LC104946 LC112954 LC024150 LC017621 LC113920 LC017046 LC017185 LC114230 LC022051 LC010500 LC117266 LC001887 LC002982 LC117324 LC102332 LC106468 LC117470 LC007590 LC100108 LC118836 LC016220 LC101309 LC120508 LC018125 LC010096 LC121590 LC022514 LC018533 LC121788 LC009410 LC002257 LC122822 LC105569 LC002521 LC116979 LC004607 LC006643 LC004836 LC109482 LC008971 LC115908 LC009077 LC123137 LC010282 LC102959 LC010363 LC020163 LC011334 LC107982 LC013964 LC118817 LC015496 LC118029 LC015554 LC119978 LC017329 LC104633 LC017436 LC020459 LC019811 LC110544 LC020468 LC113118 LC021140
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 920
Waltham MA 02451-1521
For Additional Information Contact Fresenius Medical Care Technical Service
800-227-2572 Ext. 2
Manufacturer Reason
for Recall		 Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.
FDA Determined
Cause 2		 Under Investigation by firm
Action Beginning October 24, 2023, the firm notified affected consignees via URGENT Medical Device Removal letters. Customers were instructed to reach out to their patients who had been identified as having affected cyclers to inform them that Fresenius's Technical Support team would be contacting them to arrange for a replacement. A second letter was sent to customers whose patients may potentially have affected cyclers. These customers were instructed to alert their patients of the incorrect time stamp issue. If the date and time on the patient treatment report does not match the time and date provided from the patient's last treatment, instruct your patient to contact the Fresenius Medical Care Technical Support team if they would like to have their cycler replaced. If you need any further information or support concerning this issue, please contact Fresenius Technical Support at 1-800-227-2572, option 2, and reference the Field Action Number listed above.
Quantity in Commerce 149 US
Distribution US Nationwide distribution in the states of AL, CA, FL, IL, IN, LA, MI, MO, MT, NC, NJ, NV, OH, OK, OR, PA, SC, TN, TX, VA.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FKX and Original Applicant = Fresenius Medical Care Renal Therapies Group, LLC
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