Recall Z-0799-2013 ยท FKX System, Peritoneal, Automatic Delivery
Fresenius Medical Care Holdings, Inc.
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
| Date | Feb 11, 2013 (initiated Oct 12, 2012) |
| Status | Terminated |
| Reason | There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis. |
| Root cause | Process control |
| Action | Fresenius Medical Care began contacting the affected customers by telephone and mailing an "URGENT: FMCNA LIBERTY CYCLER SET RECALL" letter and Return Receipt form dated October 31, 2012. The letters identified the specific part number and product lot and request that customers discontinue use of the lots immediately and to return unused product to FMCNA. Instructions are provided for returning the product, asking customers to isolate and discontinue use of the lot number 12BR08009 and place the product in a secure, segregated area. Consignees were instructed to contact their Fresenius Med |
| Quantity | 560 cases, totaling 5590 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 |