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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius ASSEMBLY, POWER SUPPLY

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  Class 2 Device Recall Fresenius ASSEMBLY, POWER SUPPLY see related information
Date Initiated by Firm December 16, 2014
Date Posted January 27, 2015
Recall Status1 Terminated 3 on January 29, 2021
Recall Number Z-1015-2015
Recall Event ID 70027
510(K)Number K121341  K994267  K121421  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment
2008K@home Hemodialysis Delivery System
Code Information 4P¿226813; 4P¿226815; 4P-226817; 4P-226818; 4P¿226819; 4P-226820; 4P-226821; 4P-226822
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-227-2572
Manufacturer Reason
for Recall		 Unqualified power assemblies shipped to customers.
FDA Determined
Cause 2		 Under Investigation by firm
Action Consignees were notified of the recall via letter sent on 12/18/2014 via certified mail. The letter informs consignees of the recall and requests that they take the following steps: Please check your stock for any 50 Hz Power Supplies (P/N 190092) with the name Electro Assemblies, LLC which is visible on the Transformer contained inside the Power Supply and discontinue use. Place the product in a secure, segregated area. Please contact your Fresenius Technical Services at 1-800-227-2572 option 4 then option 1, and reference the Field Action Number above. They will issue you a Return Good Authorization so you can return this product. that a reply form is completed and returned via fax or scanned email copy. In addition, consignees are asked to complete a reply form and return via fax/mail.
Quantity in Commerce 10
Distribution Distributed in OK and FL.
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 = KDI and Original Applicant = FRESENIUS MEDICAL CARE
510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE, NORTH AMERICA
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