Events

Recall of Allegiance Esmark 4" x 108" Bandage, Latex Free, Sterile

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by International Medsurg Connection, 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
    36169
  • Event Risk Class
    Class 2
  • Event Number
    Z-1527-06
  • Event Initiated Date
    2006-08-16
  • Event Date Posted
    2006-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48114
  • 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 - Product Code MHW
  • Reason
    The bandages labeled as sterile had not been sterilized prior to distribution.
  • Action
    International Medsurg Connection recalled the Esmark Bandages from Cardinal Health by telephone call on 8/16/06 and follow-up letter dated 8/24/06. The account was informed that some of the product may not have been sterilized even though it was labeled as sterile, and was requested to cease distribution of the affected lots, return the product to IMC and notify their customers to the retail level. Cardinal Health in turn notified their customers by letter dated 8/24/06, addressed to the Director of Materials Management, informing them of the possible non-sterilization of the product. Hospitals were requested to contact Cardinal Customer Service at 800-964-5227 to arrange for product return and credit or replacement of all product. All other customers were directed to call 1-888-444-5440 for product return and replacement. All questions were directed to Cardinal Quality Systems at 800-292-9332 or Mr. Manny Gupta at International Medsurg Connection at 847-619-9929.

Device

Allegiance Esmark 4" x 108" Bandage, Latex Free, Sterile
  • Model / Serial
    Catalog 24593-043A, lot 06-2071-1
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Allegiance Esmark 4' x 108' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Distributed by Cardinal Health, McGaw Park, IL 60085-8787, Made in Malaysia; Catalog 24593-043A
  • Manufacturer
    International Medsurg Connection, Inc.

Manufacturer

International Medsurg Connection, Inc.
  • Manufacturer Address
    International Medsurg Connection, Inc., 935 N Plum Grove Rd Ste F, Schaumburg IL 60173-4770
  • Manufacturer Parent Company (2017)
    International Medsurg Connection Inc.
  • Source
    USFDA