FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Renal Therapies Group, LLC: Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
- Recall number
- Z-0693-2016
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Product
- Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
- Status
- Terminated
- Initiated
- 2015-12-15
- Posted
- 2016-01-27
- Terminated
- 2019-10-07
- 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
- Lot, serial or model codes
- All lot numbers
- 510(k) numbers
- ["K043363","K123630"]
- PMA numbers
- not on file
- Product code
- FKX
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28