Events

Recall of Device Recall Xact

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
    25070
  • Event Risk Class
    Class 2
  • Event Number
    Z-316/318-3
  • Event Initiated Date
    2002-05-14
  • Event Date Posted
    2002-12-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2002-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25109
  • 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
    Accessories, Wheelchair - Product Code KNO
  • Reason
    Wheelchair seat component is defective.
  • Action
    Firm notified customers by certified letter 5/14/02 and advised of potential for serious injury. Letter instructs customers to cease use and distribution of any defective hooks and return for replacement. Firm additonally instructed dealers to notify end-users about the recall.

Device

Device Recall Xact
  • Model / Serial
    Drop Hooks are components of the wheelchair seat cushions coded as XLPD1516 XLPD1616 XLPD1618 XLPD1816 XLPD1717 XLPD1818 XLPI1516 XLPI1616 XLPI1816 XLPI1717 XLPI1818 XD... followed by one or more of the following, listed in product number: IDS, 05D, 1D, and 15D
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was sold to medical supply firms in LA, IN, and MA and to international customers.
  • Product Description
    Drop Hooks for Xact (tm) Lo-Pro with Removeable Drop Seat, Xact Integrated, and Xact Individual with Integrated Drop Seat wheelchairs, model/item numbers 05D, 1D, and 15D. Packaged as set of four in a poly bag.
  • Manufacturer
    Action Products Incorporated

Manufacturer

Action Products Incorporated
  • Manufacturer Address
    Action Products Incorporated, 22 N Mulberry Street, Hagerstown MD 21740
  • Source
    USFDA