Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23 Fairfield Place, West Caldwell, NJ 0700
FDA device recall Z-3080-2011 · posted 2011-08-29 · Terminated
Recall details
- Recalling firm
- Impact Instrumentation, Inc.
- Reason for recall
- Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k).
- Action taken
- 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
- Status
- Terminated
- Product code
- cbk
- Quantity affected
- 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.
- Date initiated
- 2011-05-27
- Date posted
- 2011-08-29
- Date terminated
- 2013-05-23
- Location
- West Caldwell, NJ
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