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U.S. Department of Health and Human Services

Class 2 Device Recall Model 754/754M Disposable MRI Ventilator Circuit

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  Class 2 Device Recall Model 754/754M Disposable MRI Ventilator Circuit see related information
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
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
Code Information Catalog/Code # 820-0092-00
Recalling Firm/
Manufacturer		 Impact Instrumentation, Inc.
23 Fairfield Pl
West Caldwell NJ 07006-6206
For Additional Information Contact Mr. Alan Giordano
973-882-1212
Manufacturer Reason
for Recall		 Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k).
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
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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