Events

Recall of Device Recall ET20 Anesthesia Extension Tubes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Global Healthcare 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
    73046
  • Event Risk Class
    Class 2
  • Event Number
    Z-0696-2016
  • Event Initiated Date
    2016-01-06
  • Event Date Posted
    2016-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142907
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.
  • Action
    Global Healthcare sent an "Urgent: DEVICE RECALL" letter dated January 6, 2015 to its Customer by email. The letter described the product, problem and actions to be taken. The customer was instructed to immediately examine its inventory to determine if you have any of the Model ET-20 on hand; if so, immediately discontinue distributing product; and complete and return the Distributor Device Recall Response Form by email. Additionally, if you have further distributed any of the product, immediately contact your accounts; advise them of recall situation and have them return their outstanding recalled stocks to you. Any returned product will be destroyed by the distributor upon receipt of all affected product. If you require further assistance, please call 770-522-7520.

Device

Device Recall ET20 Anesthesia Extension Tubes
  • Model / Serial
    Lot Number 1505201
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to state of: GA only.
  • Product Description
    ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
  • Manufacturer
    Global Healthcare Inc

Manufacturer

Global Healthcare Inc
  • Manufacturer Address
    Global Healthcare Inc, 11350 Old Roswell Rd, Suite 700, Alpharetta GA 30009-2291
  • Source
    USFDA