Events

Recall of Device Recall AC Power Cords

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by KCI USA, 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
    53802
  • Event Risk Class
    Class 2
  • Event Number
    Z-0663-2010
  • Event Initiated Date
    2009-11-04
  • Event Date Posted
    2010-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86547
  • 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
    Bed, flotation therapy, powered - Product Code IOQ
  • Reason
    Power cords may crack and fail inside plug with potential for fire hazard.
  • Action
    Kinetics Concepts, Inc. (KCI) issued an "Urgent Medical Device Correction" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product. For further information, contact KCI's technical support team at 1-800-275-4524 option #3.

Device

Device Recall AC Power Cords
  • Model / Serial
    Device Serial Numbers Affected: Tricell 60601 - Serial Numbers FSUK00011-FSUK01400; used with First Step Select - Serial Numbers FWSK00001-FSWK02393; and used with Plexipulse - Serial Numbers PPGK00001-PPGK00226.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4102204 used with Tricell 60601 Model 212857, First Step Select Model 215200 , and Plexipulse Model 205835.
  • Manufacturer
    KCI USA, Inc.

Manufacturer

KCI USA, Inc.
  • Manufacturer Address
    KCI USA, Inc., 4958 Stout Dr, San Antonio TX 78219-4334
  • Source
    USFDA