Recall Z-0148-2014
Fresenius Medical Care Holdings, Inc. · initiated October 14, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
Codes / lots: All serial numbers
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: Device Design
Action taken
Fresenius 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.
Details
- Recall number
- Z-0148-2014
- Initiated
- October 14, 2013
- Posted by FDA
- November 5, 2013
- Terminated
- May 18, 2021
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Quantity
- 16,600
- Distribution
- USA Nationwide Distribution
- Recalling firm
- Fresenius Medical Care Holdings, Inc., Waltham, MA