Events

Recall of Device Recall Carepak

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

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
    71682
  • Event Risk Class
    Class 2
  • Event Number
    Z-2460-2015
  • Event Initiated Date
    2015-06-10
  • Event Date Posted
    2015-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138730
  • 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
    Contain 0.1% benzalkonium chloride in the 5/8 bandages inside the assortment which is not listed as an active ingredient in the product label.
  • Action
    Customers were contacted by phone and e-mail on 06/10/2015; First class letter was sent on 06/23/2015.

Device

Device Recall Carepak
  • Model / Serial
    Model #141168; Lots #s 00013359, 00020722 and 00028721.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to Rhode Island only
  • Product Description
    Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
  • Manufacturer
    ASO, LLC

Manufacturer

ASO, LLC
  • Manufacturer Address
    ASO, LLC, 300 Sarasota Center Blvd, Sarasota FL 34240-9381
  • Manufacturer Parent Company (2017)
    Aso Corporation
  • Source
    USFDA