Recall Z-0104-2011
Fresenius Medical Care Holdings, Inc. · initiated September 3, 2010
Product
LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Single Patient Connector) PIN: 050-87215. manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.
Codes / lots: Lot Number Expiration Date 09CR08086 03/31/2012 09DR08038 04/30/2012 09JR08092 07/31/2012 09JR08093 07/31/2012 09KR08061 08/31/2012
Reason for recall
Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-0104-2011
- Initiated
- September 3, 2010
- Posted by FDA
- October 20, 2010
- Terminated
- February 16, 2023
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Quantity
- 1524 units
- Distribution
- Nationwide Distribution: Throughout USA.
- Recalling firm
- Fresenius Medical Care Holdings, Inc., Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0103-2011 | LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors…Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially… | 09/03/2010Terminated |
| Z-0105-2011 | LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe…Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially… | 09/03/2010Terminated |