Recall Z-0103-2011 ยท FKX System, Peritoneal, Automatic Delivery
Fresenius Medical Care Holdings, Inc.
LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212, manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.
| Date | Oct 20, 2010 (initiated Sep 3, 2010) |
| Status | Terminated |
| Reason | Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis. |
| Root cause | Nonconforming Material/Component |
| Action | Fresenius Medical Care issued an Urgent FMCNA LIBERTY Cycler Set Recall letter on September 3, 2010 identifying the specific affected part numbers and product lots and requesting that customers identify and discontinue the use of the affected lots immediately. Customers were requested to return a receipt of notification. Customers may arrange return unused product to FMCNA by contacting customer service at 1-800-323-5188. |
| Quantity | 363,265 units |
| Distribution | Nationwide Distribution: Throughout USA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043363 | FRESENIUS LIBERTY CYCLER Fresenius Medical Care North America, Mar 31, 2005 |