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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 FirmOctober 14, 2013
Date PostedNovember 05, 2013
Recall Status1 Terminated 3 on May 18, 2021
Recall NumberZ-0148-2014
Recall Event ID 66339
510(K)NumberK043363 
Product Classification System, peritoneal, automatic delivery - Product Code FKX
ProductFresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-662-1237
Manufacturer Reason
for Recall		Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis
FDA Determined
Cause 2		Device Design
ActionFresenius Medical Care contacted all affected consignees by telephone on 10/14/13 to inform them of the product safety alert. Follow-up Urgent Safety Alert letter was sent on 10/18/13 and 10/23/13 by Certified Mail, Return Receipt requested. The letter identified the affected product, problem and actions to be taken. Customers were instructed to report any events associated with this safety alert to Customer Service Team at 1-800-323-5188.
Quantity in Commerce16,600
DistributionUSA Nationwide Distribution
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 = FKX
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