Events

Recall of AGI2238 Portable 4 Cylinder Manifold Cart

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Airgas Puritan Medical.

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
    53081
  • Event Risk Class
    Class 2
  • Event Number
    Z-0038-2010
  • Event Initiated Date
    2009-08-06
  • Event Date Posted
    2009-10-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84606
  • 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
    medical gas cylinder connectors - Product Code CAN
  • Reason
    Yoke may become displaced. yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.
  • Action
    Airgas issued a Medical Device Removal letter dated 8/6/09 to its customers informing them of the problem and the need to have a yoke back-up plate installed on the Manifold Block Assembly.

Device

AGI2238 Portable 4 Cylinder Manifold Cart
  • Model / Serial
    All units of model numbers 8065-870 and 8066-910
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
  • Manufacturer
    Airgas Puritan Medical

Manufacturer

Airgas Puritan Medical