Events

Recall of Device Recall Esmark Elastic Bandage, 4" x 3 yards

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

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
    50198
  • Event Risk Class
    Class 2
  • Event Number
    Z-0616-2009
  • Event Initiated Date
    2008-11-18
  • Event Date Posted
    2009-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74942
  • 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
    Bandage, elastic - Product Code FQM
  • Reason
    The natural rubber latex bandages were mislabeled as latex free.
  • Action
    A recall letter dated 11/17/08 was issued to the Directors of Materials Management and sent via DHL 2-day service on 11/18/08. Accounts were advised that the elastic bandages containing latex were mislabeled as latex free. Customers were requested to return their inventories of the affected product to Cardinal Health for credit or replacement by calling the Presource Customer Sales Operations Group at 800-766-0706 for return instructions. Customers were also requested to complete the enclosed Cardinal Customer Acknowledgement form by indicating the amount of affected product being returned and fax it to 847-689-9101. Please direct questions to Quality Systems, Professional Services at 800-292-9332.

Device

Device Recall Esmark Elastic Bandage, 4" x 3 yards
  • Model / Serial
    Catalog number 23580-043: Work order numbers 310652, 316815, 324060 and 327413.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA, Guam and Korea.
  • Product Description
    Esmark Elastic Bandage, 4" x 3 yards, sterile, for single use only, latex free. Distributed by Cardinal Health, McGaw Park, IL 60085-6787. || The device is used to promote blood flow from the extremities by compressing the superficial vessels.
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Manufacturer Address
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA