Events

Recall of Device Recall Chemetron

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Allied Healthcare Products 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
    52383
  • Event Risk Class
    Class 2
  • Event Number
    Z-2031-2009
  • Event Initiated Date
    2009-05-15
  • Event Date Posted
    2009-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82816
  • 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
    compressed gas cylinder and valve - Product Code ECX
  • Reason
    Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
  • Action
    The recalling firm first notified their customers via a letter dated 5/15/09 issued regular mail explaining the reason for recall and requesting the cylinders with specific post valves be returned. A second letter dated 6/1/09 was issued via regular mail which provided specific shipping dates that each customer received the suspect product. Neither of these two letters requested subrecall. A third letter dated 6/17/09, which included copies of the first two letters, via certified mail. This letter informed the customer the recall was to be conducted to the user level and requested their customer conduct a subrecall. Requested to remove the cylinder from service and call Allied Healthcare Products for return and a replacement at 1-800-268-1661.

Device

Device Recall Chemetron
  • Model / Serial
    InterMed 08-05-3B and InterMed 09-01-1B located on the post valve.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Class II Recall Worldwide Distribution including states of NY, NC, KY, PA, WI, NH, NJ, CA, CT, FL and Singapore.
  • Product Description
    First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually packaged regulator, cannula, and bag mask resuscitator, all packaged in a shipping container labeled as: Product #L903, Desc FIRST RESPONDER KIT, Catalog #L903. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
  • Manufacturer
    Allied Healthcare Products Inc

Manufacturer

Allied Healthcare Products Inc
  • Manufacturer Address
    Allied Healthcare Products Inc, 1720 Sublette Ave, St. Louis MO 63110
  • Manufacturer Parent Company (2017)
    Allied Healthcare Products Inc.
  • Source
    USFDA