| Class 3 Device Recall Liberty Select Cycler |  |
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.
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510(K) Database | 510(K)s with Product Code = FKX
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