Recall Z-1674-2013 ยท FKX System, Peritoneal, Automatic Delivery
Fresenius Medical Care Holdings, Inc.
Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.
| Date | Jul 10, 2013 (initiated Jun 3, 2013) |
| Status | Terminated |
| Reason | Cassette may leak during set up or during peritoneal dialysis treatment |
| Root cause | Unknown/Undetermined by firm |
| Action | Fresenius Medical Care sent a Urgent Recall letter dated June 11, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their stock immediately and discontinue use and return product. Please contact your Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions to return the product. |
| Quantity | 5480 units |
| Distribution | Nationwide Distribution |
| 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 |