Events

Recall of Device Recall Aplicare Advantage Dressing Change System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aplicare, 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
    54823
  • Event Risk Class
    Class 3
  • Event Number
    Z-1310-2010
  • Event Initiated Date
    2010-03-03
  • Event Date Posted
    2010-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89252
  • 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
    Central Line Dressing Change - Product Code NAD
  • Reason
    Incorrect expiration date on outer kit label-extended.
  • Action
    Aplicare notified customers by telephone on March 3, 2010 followed with "Product Recall Notice" letter issued by e-mail to the distributor level. Product will be labeled with correct expiration date. Direct questions to your sales representative or customer service by calling 1-800-760-3236.

Device

Device Recall Aplicare Advantage Dressing Change System
  • Model / Serial
    Lot number: 35397.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    United States (CT, RI, NJ and OH).
  • Product Description
    Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile || Part number: A3402. || The product is used for Central Line Dressing Change.
  • Manufacturer
    Aplicare, Inc.

Manufacturer

Aplicare, Inc.
  • Manufacturer Address
    Aplicare, Inc., 550 Research Pkwy, Meriden CT 06450-7172
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA