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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius 2008T Hemodialysis Machine

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  Class 2 Device Recall Fresenius 2008T Hemodialysis Machine see related information
Date Initiated by Firm January 19, 2011
Date Posted March 04, 2011
Recall Status1 Terminated 3 on July 08, 2013
Recall Number Z-1526-2011
Recall Event ID 57851
510(K)Number K0933902  
Product Fresenius 2008T Hemodialysis Machine
Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS
Part Number 190713, 2008T Hemodialysis System with CDX
Part Number 190766, 2008T Hemodialysis System with biBag

The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
Code Information Units distributed between Sept 1, 2010 and January 5, 2011. Serial 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 
Recalling Firm/
Manufacturer
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact SAME
800-662-1237
Manufacturer Reason
for Recall
Cursor on the dialysis screen may disappear and not respond to user input
FDA Determined
Cause 2
Device Design
Action Fresenius Medical Care contacted customers by mailing a Customer Notification letter "Urgent correction FMNCA Model 2008T Hemodialysis Machine" via Certified-Mail, Return Receipt requested on January 19, 2011. The Technical Services department began contacting consignees by telephone on January 13, 2011, to schedule an appointment for installing the electronic board on the 2008T machines at the customers' facilities. For questions call Technical services 1-800-227-2572.
Quantity in Commerce 1268 units
Distribution Worldwide Distribution - USA and Canada

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.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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