Events

Recall of BE 183 Series Manual Jet Ventilator with Regulator and Gauge.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Instrumentation Industries 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
    27419
  • Event Risk Class
    Class 2
  • Event Number
    Z-0556-04
  • Event Initiated Date
    2003-09-12
  • Event Date Posted
    2004-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29855
  • 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, Manual (Resuscitator) - Product Code BTM
  • Reason
    Possible external debris in the on/off plunger.
  • Action
    The recalling firm notified all customers via telephone to inform them of the problem and the need to return the product when received. The recalling firm issued recall letters dated 9/17/03 to their direct accounts informing them of the problem. The also informed the account that a stop shipment had been ordered but if they receive the product they need to return it immediately.

Device

BE 183 Series Manual Jet Ventilator with Regulator and Gauge.
  • Model / Serial
    Part number BE183-SUR, Lot number P0908103
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to medical facilities in CA, FL, GA, NY, OH, OR, TX, and UT.
  • Product Description
    BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator with Regulator and Gauge.
  • Manufacturer
    Instrumentation Industries Inc

Manufacturer

Instrumentation Industries Inc
  • Manufacturer Address
    Instrumentation Industries Inc, 2990 Industrial Blvd, Bethel Park PA 15102
  • Source
    USFDA