Recall Z-0105-2011 ยท FKX System, Peritoneal, Automatic Delivery
Fresenius Medical Care Holdings, Inc.
LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe patient connector and extended drain line PIN: 050-87216. 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 | 5799 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 |