Z-0870-2012

Model 73X Uni-Vent

Name: Z-0870-2012 Model 73X Uni-Vent
Creator: Impact Instrumentation, Inc.
Published: 2011-11-04
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2011-11-04 / Terminated / root cause: design

FDA source

Impact Instrumentation, Inc. began a recall of Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents on 2011-11-04. The reason FDA records is "A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0870-2012
Status: Terminated
Initiated: 2011-11-04
Posted: 2015-06-26
Terminated: 2013-05-23
Recalling firm: ZOLL Medical Corporation
Product: Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents.
Product code: BTL Ventilator, Emergency, Powered (Resuscitator)
Reason for recall: A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device.
Root cause tag: design
FDA root cause: Component design/selection
Action: Impact Instrumentation Inc. sent an URGENT Device Product Recall letter dated November 3, 2011 to all affected consignees. The letter identified the product, problem, instructions for product returns, and actions to be taken. The letter states that Impact will arrange for expedited return, at no charge to the customers of the affected units. The notice instructs customers to complete and return the Recall Tracking Form. If you need additional information, please call Impact Customer Service at (800) 969-0750
Quantity in commerce: 57 units
Distribution: Worldwide Distribution - USA (nationwide)
Product codes and lots: K051476

Product code BTL

K051476Class IIUni-Vent Model 73XImpact Instrumentation, Inc. / cleared 2005-10-28

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)