Recall Z-1448-2012 ยท FKX System, Peritoneal, Automatic Delivery
Fresenius Medical Care Holdings, Inc.
Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8. The Fresenius Liberty Cycler is intended for acute or chronic peritoneal dialysis.
| Date | Apr 24, 2012 (initiated Mar 30, 2012) |
| Status | Terminated |
| Reason | Increased risk of intraperitoneal volume (IIPV), referred to as Overfill |
| Root cause | Software design |
| Action | Fresenius Medical Care sent a Urgent Product Information letter dated March 30, 2012, and April 3, 2012, to all affected customers. The letter was sent via Certified Mail, Return Receipt Requested. The letter identified the product the problem and the action needed to be taken by the customer. Recall to occur in 2 phases: Phase I: Fresenius Medical Care notified all clinics with patients using Liberty Cyclers with software versions earlier than 2.8 that these patients are receiving updated User Manuals and Handi-Guides. These new materials will include updated descriptions of the safety w |
| Quantity | 10,146 units |
| Distribution | Worldwide Distribution -- USA (nationwide) |
| 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 |