Z-3080-2011

Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23 Fairfield Place, West...

Name: Z-3080-2011 Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23 Fairfield Place, West...
Creator: Impact Instrumentation, Inc.
Published: 2011-05-27
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2011-05-27 / Terminated / root cause: labeling and UDI

FDA source

Impact Instrumentation, Inc. began a recall of Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23 Fairfield Place, West Caldwell, NJ 07006. Accessory for 700 Series 754/754m... on 2011-05-27. The reason FDA records is "Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3080-2011
Status: Terminated
Initiated: 2011-05-27
Posted: 2011-08-29
Terminated: 2013-05-23
Recalling firm: ZOLL Medical Corporation
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
Product code: cbk
Reason for recall: Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k).
Root cause tag: labeling and UDI
FDA 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 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.
Product codes and lots: Catalog/Code # 820-0092-00

Product code cbk

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)