Recall Z-0693-2016 ยท FKX System, Peritoneal, Automatic Delivery
Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
| Date | Jan 27, 2016 (initiated Dec 15, 2015) |
| Status | Terminated |
| Reason | The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill). |
| Root cause | Device Design |
| Action | Fresenius Medical Care issued on December 15, 2015, a n Important Product Notification to all affected customers informing them of the problem and how to recognize the proper latch closing. Questions regarding the contents of the Customer Notification or questions regarding the issue, contact Technical Services at 1-800-227-2572 and reference the Field Action Number FA-2015-10-W. A reply form is included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. |
| Quantity | 14,094 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |