Events

Recall of Device Recall Model EMV UniVent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Impact Instrumentation, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62535
  • Event Risk Class
    Class 3
  • Event Number
    Z-2152-2012
  • Event Initiated Date
    2012-03-19
  • Event Date Posted
    2012-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110872
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, facility use - Product Code CBK
  • 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.
  • 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.

Device

Device Recall Model EMV UniVent
  • Model / Serial
    Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of Illinois.
  • 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.
  • Manufacturer
    Impact Instrumentation, Inc.

Manufacturer

Impact Instrumentation, Inc.
  • Manufacturer Address
    Impact Instrumentation, Inc., 23 Fairfield Pl, West Caldwell NJ 07006-6206
  • Manufacturer Parent Company (2017)
    Asahi Kasei Corp.
  • Source
    USFDA