Date Initiated by Firm |
October 23, 2015 |
Create Date |
November 18, 2015 |
Recall Status1 |
Terminated 3 on March 02, 2021 |
Recall Number |
Z-0296-2016 |
Recall Event ID |
72484 |
510(K)Number |
K131611
|
Product Classification |
Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
|
Product |
Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075.
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 |
992 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 MEDICAL CARE NORTH AMERICA
|