Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
This recall has been terminated (originally issued February 11, 2013).
- Recall Initiated
- October 12, 2012
- Posted
- February 11, 2013
- Terminated
- December 30, 2020
- Recall Number
- Z-0799-2013
- Quantity
- 560 cases, totaling 5590 units
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Lot 12BR08009
Root Cause
Process control
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.