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U.S. Department of Health and Human Services

Medical Device Recalls

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  Medical Device Recalls see related information
Date Initiated by Firm June 03, 2013
Create Date July 10, 2013
Recall Status1 Terminated 3
Recall Number Z-1674-2013
Recall Event ID 65332
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.

Recalling Firm/
Manufacturer
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-662-1237
Manufacturer Reason
for Recall
Cassette may leak during set up or during peritoneal dialysis treatment
Action 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.
Quantity in Commerce 5480 units
Distribution Nationwide Distribution

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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