Events

Recall of Device Recall UNIVENT MODEL 73X

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
    60786
  • Event Risk Class
    Class 2
  • Event Number
    Z-0870-2012
  • Event Initiated Date
    2011-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106467
  • 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, emergency, powered (resuscitator) - Product Code BTL
  • Reason
    A piece of internal tubing in the 73x portable ventilator is of incorrect specifications for the device.
  • Action
    Impact Instrumentation Inc. sent an URGENT Device Product Recall letter dated November 3, 2011 to all affected consignees. The letter identified the product, problem, instructions for product returns, and actions to be taken. The letter states that Impact will arrange for expedited return, at no charge to the customers of the affected units. The notice instructs customers to complete and return the Recall Tracking Form. If you need additional information, please call Impact¿ Customer Service at (800) 969-0750

Device

Device Recall UNIVENT MODEL 73X
  • Model / Serial
    K051476
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Product Description
    Model 73X Uni-Vent || Product Usage: Intended for use at mass casualty incidents.
  • 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