Events

Recall of Flexible Support Arm Assembly

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
    33923
  • Event Risk Class
    Class 2
  • Event Number
    Z-0427-06
  • Event Initiated Date
    2005-10-14
  • Event Date Posted
    2006-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42748
  • 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
    Support, Breathing Tube - Product Code JAY
  • Reason
    Potential for the flexible tube portion of the assembly to become brittle and break.
  • Action
    All customers (and/or end-users) were notified on October 14 and 17, 2005 by telephone. Formal notification letters were sent (certified) to each customer (and/or end-user) on October 17 and 18, 2005.

Device

Flexible Support Arm Assembly
  • Model / Serial
    Lot numbers PO902505 and PO900805
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The products were shipped to medical facilities in FL, NY, and WV.
  • Product Description
    Flexible Support Arm Assembly. Breathing Tube Support. Catalog number BE 122-30
  • Manufacturer
    Instrumentation Industries Inc

Manufacturer

Instrumentation Industries Inc