Recall Z-3080-2011
Impact Instrumentation, Inc. · initiated May 27, 2011
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
Codes / lots: Catalog/Code # 820-0092-00
Reason for recall
Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k).
FDA-determined cause: Labeling False and Misleading
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.
Details
- Recall number
- Z-3080-2011
- Initiated
- May 27, 2011
- Posted by FDA
- August 29, 2011
- Terminated
- May 23, 2013
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Quantity
- 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.
- Recalling firm
- Impact Instrumentation, Inc., West Caldwell, NJ