Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perf
FDA device recall Z-0148-2014 · posted 2013-11-05 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- 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
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- 16,600
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2013-10-14
- Date posted
- 2013-11-05
- Date terminated
- 2021-05-18
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS LIBERTY CYCLER (K043363) | Fresenius Medical Care North America | 2005-03-31 |