Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
FDA device recall Z-0799-2013 · posted 2013-02-11 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.
- Action taken
- Fresenius Medical Care began contacting the affected customers by telephone and mailing an "URGENT: FMCNA LIBERTY CYCLER SET RECALL" letter and Return Receipt form dated October 31, 2012. The letters identified the specific part number and product lot and request that customers discontinue use of the lots immediately and to return unused product to FMCNA. Instructions are provided for returning the product, asking customers to isolate and discontinue use of the lot number 12BR08009 and place the product in a secure, segregated area. Consignees were instructed to contact their Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- 560 cases, totaling 5590 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-10-12
- Date posted
- 2013-02-11
- Date terminated
- 2020-12-30
- 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 |