Class 2 Device Recall Fresenius

• Date Initiated by Firm: May 04, 2011
• Date Posted: August 29, 2011
• Recall Status: Terminated on August 14, 2014
• Recall Number: Z-3083-2011
• Recall Event ID: 59483
• 510(K)Number: K070049
• Product Classification: Hemodialysis system for home use - Product Code ONW
• Product: Fresenius 2008K@home The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
• Code Information: All serial numbers
• 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: Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k)
• FDA Determined Cause: Device Design
• Action: Fresenius Medical NA issued a formal field correction notification dated May 4 ,2011, sent by certified mail with return receipt requested. The letter identified the product the problem and the action needed to be taken by the customer. The customer was notified of the retrofit that would be done to their machines. The patients' facilities were made aware of the changes that would be made to each of their patient's 2008K@home machines on May 4, 2011. On May 13, 2011, all facilities with active 2008K@home machines were sent a notification letter of the retrofit. Please return the receipt for confirmation that you have received this notice. Please call (781) 699-2053, to schedule a certified technician to conduct the machine retrofit.
• Quantity in Commerce: 705 units
• Distribution: Nationwide Distribution. Canada - FMCNA is not conducting the recall to Canada, as Health Canada did not require the same modifications to the machines
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = ONW