LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe patient connector and extended
FDA device recall Z-0105-2011 · posted 2010-10-20 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.
- Action taken
- Fresenius Medical Care issued an Urgent FMCNA LIBERTY Cycler Set Recall letter on September 3, 2010 identifying the specific affected part numbers and product lots and requesting that customers identify and discontinue the use of the affected lots immediately. Customers were requested to return a receipt of notification. Customers may arrange return unused product to FMCNA by contacting customer service at 1-800-323-5188.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- 5799 units
- Distribution
- Nationwide Distribution: Throughout USA.
- Date initiated
- 2010-09-03
- Date posted
- 2010-10-20
- Date terminated
- 2023-02-16
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS LIBERTY CYCLER (K043363) | Fresenius Medical Care North America | 2005-03-31 |