Recall Z-3080-2011 ยท CBK Ventilator, Continuous, Facility Use
Impact Instrumentation, Inc.
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
| Date | Aug 29, 2011 (initiated May 27, 2011) |
| Status | Terminated |
| Reason | Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k). |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.