Z-2152-2012Class III

Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated...

Name: Z-2152-2012 Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated...
Creator: Impact Instrumentation, Inc.
Published: 2012-03-19
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2012-03-19 / Terminated / root cause: manufacturing process

FDA source

Impact Instrumentation, Inc. began a recall of Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic... on 2012-03-19. FDA classified it as Class III and gives the reason as "Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2152-2012
Classification: Class III
Status: Terminated
Initiated: 2012-03-19
Posted: 2012-08-07
Terminated: 2012-08-15
Recalling firm: ZOLL Medical Corporation
Product: Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Impact Instrumentation Inc. notified their sole customer via email on 3/15/12 and then emailed an "Urgent Device Product Recall" letter and tracking form dated 3/19/2012. The letter described the reason for the recall and provided recommended actions and the contact number for Customer Service.
Quantity in commerce: Ten Units
Distribution: US Distribution to the state of Illinois.
Product codes and lots: Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2152-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2152-2012	Class III	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-07

Product code CBK

K103318Class IIUni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc. / cleared 2011-04-07

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)