Events

Recall of Device Recall BolXII

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

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
    53041
  • Event Risk Class
    Class 2
  • Event Number
    Z-2236-2009
  • Event Initiated Date
    2009-06-26
  • Event Date Posted
    2009-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84506
  • 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
    bolus pad - Product Code JAD
  • Reason
    Medical device intended for use by healthcare practitioners was incorrectly labeled. 1.0 cm thick pad was labeled as 0.5 cm thickness, and vice versa.
  • Action
    Action Products Inc. notified one affected distributor by phone and email on 06/26/09 and issued a Return Merchandise Authorization.

Device

Device Recall BolXII
  • Model / Serial
    I1PSX-0000
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy.
  • Manufacturer
    Action Products Incorporated

Manufacturer

Action Products Incorporated
  • Manufacturer Address
    Action Products Incorporated, 954 Sweeney Dr, Hagerstown MD 21740-7111
  • Manufacturer Parent Company (2017)
    Action Products Inc.
  • Source
    USFDA