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Terminated

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

FDA Recall Z-3080-2011 · Posted 2011-08-29

Recalling FirmImpact Instrumentation, Inc.
Recall StatusTerminated
Product Codecbk
Date Initiated2011-05-27
Date Terminated2013-05-23
Product Quantity492 units

Reason for Recall

Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k).

Firm 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.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide Distribution; including the states of CA, FL, IL, NJ, OH, TX, UT, MN, MO, MS, OH, OR, TX, AR, and PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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