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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius 132 Gallon GranuFlo Dissolution Unit

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  Class 2 Device Recall Fresenius 132 Gallon GranuFlo Dissolution Unit see related information
Date Initiated by Firm October 23, 2015
Create Date November 18, 2015
Recall Status1 Terminated 3 on March 02, 2021
Recall Number Z-0294-2016
Recall Event ID 72484
510(K)Number K911459  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101.

For Use in the Preparation of acid concentrate for hemodialysis.
Code Information All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.
Recalling Firm/
Manufacturer		 Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact SAME
781-699-9000
Manufacturer Reason
for Recall		 Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
FDA Determined
Cause 2		 Device Design
Action Fresenius issued an Urgent - Medical Device Correction notification, dated October 21, 2015, on 10/27/15. The letter identified the affected device and the reason for the recall. It also contained instructions (on how to perform the required wiring modification) along with a Reply Form. Customers are to return the form after completing the modification. Inquiries regarding the correction should be directed to Fresenius Technical Services at 800-227-2572, referencing the Field Action number FA-2015-01-W.
Quantity in Commerce 918 units
Distribution Nationwide Distribution.
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 = KPO and Original Applicant = FRESENIUS USA, INC.
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