Impact Instrumentation, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2152-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: March 19, 2012

Date Posted: August 15, 2012

Recall Number: Z-2152-2012

Event ID: 62535

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.

Status: Terminated

Product Quantity: Ten Units

Code Information:

Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297.

Distribution Pattern:

US Distribution to the state of Illinois.

Voluntary or Mandated:

Voluntary: Firm initiated