Recall Z-1674-2013
Fresenius Medical Care Holdings, Inc. · initiated June 3, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.
Codes / lots: Lot 11PR08083
Reason for recall
Cassette may leak during set up or during peritoneal dialysis treatment
FDA-determined cause: Unknown/Undetermined by firm
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.
Details
- Recall number
- Z-1674-2013
- Initiated
- June 3, 2013
- Posted by FDA
- July 10, 2013
- Terminated
- June 18, 2014
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Quantity
- 5480 units
- Distribution
- Nationwide Distribution
- Recalling firm
- Fresenius Medical Care Holdings, Inc., Waltham, MA