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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 Recall
Model 754/754M Disposable MRI Ventilator Circuit
see related information
Date Posted August 29, 2011
Recall Status1 Terminated on May 23, 2013
Recall Number Z-3080-2011
Recall Event ID 59400
Product Classification Ventilator, Continuous, Facility Use - 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/
Impact Instrumentation, Inc.
23 Fairfield Pl
West Caldwell, New Jersey 07006-6206
For Additional Information Contact Mr. Alan Giordano
Manufacturer Reason
for Recall
Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k).
FDA Determined
Cause 2
MISBRANDING: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.