Recall Z-0693-2016
Fresenius Medical Care Renal Therapies Group, LLC · initiated December 15, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
Codes / lots: All lot numbers
Reason for recall
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).
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0693-2016
- Initiated
- December 15, 2015
- Posted by FDA
- January 27, 2016
- Terminated
- October 7, 2019
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Quantity
- 14,094 units
- Distribution
- Nationwide Distribution
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA