Events

Recall of Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.

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
    28201
  • Event Risk Class
    Class 2
  • Event Number
    Z-0709-04
  • Event Initiated Date
    2004-02-02
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31369
  • 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 may not properly support the user due to cracks in the plastic seat base.
  • Action
    The recalling firm notified dealers by certified letter on 1/19/03. The notification was flagged Attention:Product Recall and advised of seat base susceptibility to cracks and breakage. Dealers were intructed to respond with end user information. Dealers were also provided instructions and materials for crossbar and safety lock installation used with the drop seat bases. Dealers were additionally instructed to forward the provided notification letters to end users.

Device

Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Dr...
  • Model / Serial
    Drop seat bases are not labeled with serial or code numbers, but are found on all wheelchair cushions labeled as Xact Integrated and Xact Individual w/Drop Seat Base.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was sold to medical device dealers, primarily pharmacies, nationwide and internationally.
  • Product Description
    Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.
  • Manufacturer
    Action Products Incorporated

Manufacturer

Action Products Incorporated
  • Manufacturer Address
    Action Products Incorporated, 22 N Mulberry St, Hagerstown MD 21740-4910
  • Source
    USFDA