Recall Z-0834-06 ยท FKX System, Peritoneal, Automatic Delivery
Fresenius Medical Care North America
Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028
| Date | May 3, 2006 (initiated Mar 22, 2006) |
| Status | Terminated |
| Reason | Stay safe trigger body may not connect to the extension set and result in associated peritonitis |
| Root cause | Other |
| Action | Fresenius Medical notified customers by telephone on 3/24/06 for initial lots recalled and followed by letter dated 3/30/06 to include all lots numbers recalled. |
| Quantity | 141,770 units |
| Distribution | Nationwide Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002892 | FRSENIUS PD IQCARD CYCLER Fresenius Medical Care North America, Apr 5, 2001 |