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Class 2 Device Recall Model 754/754M Disposable MRI Ventilator Circuit |
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Date Initiated by Firm |
May 27, 2011 |
Date Posted |
August 29, 2011 |
Recall Status1 |
Terminated 3 on May 23, 2013 |
Recall Number |
Z-3080-2011 |
Recall Event ID |
59400 |
Product Classification |
Ventilator Accessory, Continous - Product Code cbk
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Product |
Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23 Fairfield Place, West Caldwell, NJ 07006.
Accessory for 700 Series 754/754m Ventilators during MRI examinations
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Code Information |
Catalog/Code # 820-0092-00 |
Recalling Firm/ Manufacturer |
Impact Instrumentation, Inc. 23 Fairfield Pl West Caldwell NJ 07006-6206
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For Additional Information Contact |
Mr. Alan Giordano 973-882-1212
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Manufacturer Reason for Recall |
Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k).
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FDA Determined Cause 2 |
Labeling False and Misleading |
Action |
Impact Instrumentation Inc. sent an "Urgent Product Recall" dated May 27, 2011 to all affected customers.
The letter informed customers the product is not a cleared product and to return the product back to Impact Inst. for credit. A notification form is included in the letter to be return to the firm.
For information on this recall contact the firms Customer Service Department at (800) 969-0750, 8:30 am to 5:00 pm EST. |
Quantity in Commerce |
492 units |
Distribution |
Nationwide Distribution; including the states of CA, FL, IL, NJ, OH, TX, UT, MN, MO, MS, OH, OR, TX, AR, and PA. |
Total Product Life Cycle |
TPLC Device Report
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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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