Events

Recall of Device Recall Curad Flexible Fabric Bandage

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Jiangsu Wujin Hualian Health Dressing Co., Ltd..

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
    58198
  • Event Risk Class
    Class 2
  • Event Number
    Z-2198-2011
  • Event Initiated Date
    2011-02-22
  • Event Date Posted
    2011-05-13
  • 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=99526
  • 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
    Tape and bandage, adhesive - Product Code KGX
  • Reason
    The sterility of the product has the potential to be compromised due to weak sealing of the bandages.
  • Action
    Changzhou Hualian Health Dressing Co., Ltd notified sole consignee by e-mail and a Medical Device Recall letter, dated 3/18/2011. The letter identifies the affected product and the reason for the recall. The customer was to examine their inventory and quarantine the affected product. If the product had been further distributed, those customers were to be identified and notified of the recall. The enclosed response form was to be completed and returned to Medline Industries, Inc. Questions could be directed to Customer Service, Monday through Friday between 8:30 A.M. and 4:00 P.M.

Device

Device Recall Curad Flexible Fabric Bandage

Manufacturer

Jiangsu Wujin Hualian Health Dressing Co., Ltd.
  • Manufacturer Address
    Jiangsu Wujin Hualian Health Dressing Co., Ltd., 55 Yuejin Rd., Zouqu Town, Wujin City, Jiangsu Prov. China
  • Source
    USFDA