Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
FDA device recall Z-0693-2016 · posted 2016-01-27 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- 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).
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- 14,094 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-12-15
- Date posted
- 2016-01-27
- Date terminated
- 2019-10-07
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS LIBERTY CYCLER (K123630) | Fresenius Medical Care North America, Design Cente | 2013-09-09 |
| FRESENIUS LIBERTY CYCLER (K043363) | Fresenius Medical Care North America | 2005-03-31 |