Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Model 731 EMV+ Uni-Vent Recalled by Impact Instrumentation, Inc. Due to Ten units of Model EMV+ Devices were shipped...

Date: March 19, 2012
Company: Impact Instrumentation, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Impact Instrumentation, Inc. directly.

Affected Products

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.

Quantity: Ten Units

Why Was This Recalled?

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.

Where Was This Sold?

US Distribution to the state of Illinois.

About Impact Instrumentation, Inc.

Impact Instrumentation, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report