Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with int
FDA device recall Z-1674-2013 · posted 2013-07-10 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Cassette may leak during set up or during peritoneal dialysis treatment
- Action taken
- Fresenius Medical Care sent a Urgent Recall letter dated June 11, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their stock immediately and discontinue use and return product. Please contact your Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions to return the product.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- 5480 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-06-03
- Date posted
- 2013-07-10
- Date terminated
- 2014-06-18
- 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 |