Recall Z-2152-2012— Impact Instrumentation, Inc.

Name: FDA recall Z-2152-2012
Creator: U.S. Food and Drug Administration
Published: 2012-03-19

Class III · Terminated

Class III FDA medical device recall by Impact Instrumentation, Inc., initiated 2012-03-19, terminated 2012-08-15. It names one FDA 510(k) clearance: K103318. 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.. Reason: 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..

Recalling firm: Impact Instrumentation, Inc.
Classification: Class III
Status: Terminated
Initiated: 2012-03-19
Terminated: 2012-08-15
Firm location: West Caldwell, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K103318 — UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATORImpact Instrumentation, Inc.·cleared 2011-04-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.