Recall of Precision Ice

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pro Trainers' Choice Company.

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
    58770
  • Event Risk Class
    Class 2
  • Event Number
    Z-2659-2011
  • Event Initiated Date
    2011-04-18
  • Event Date Posted
    2011-06-24
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-03-01
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Pack (hot/cold) water circulating - Product Code ILO
  • Reason
    The control panel of the precision ice one patient use control unit and wrap system has a overheating issue. the control panel printed circuit boards were missing a jumper connection across resistors r28 a, b, c, and d.
  • Action
    Pro Trainers' Choice sent a Mandate-Medical Device Recall on April 18, 2011 and April 20, 2011 to all affected costumers. The letter included a description of the product, affected model and lots. It instructed the costumers to discontinue using the Precision Ice, Model 4BBK02BK until the device is returned and corrected by Pro Trainers' Choice. The device should be returned to PO Box 27, Kingston, WA 98346. The customers were instructed to notify their sub-account customers of this recall if the devices were further distributed. Customers can call Pro Trainers' Choice Company at 360-297-3902 or visit the website www.precisionice.com for any questions about this recall.

Device

  • Model / Serial
    The affected serial numbers range from 100116 to 100452.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution including CA, CO, FL, IN, KS, NY, OR, TX, and WI.
  • Product Description
    Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). || The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. || The owner's manual is labeled in part: "PRO TRAINERS' CHOICE COMPANY, INC.***www.precisionice.com***info@precisionice.com***Mailing Address PO Box 27***Kingston, WA 98346 USA***Phone: 360-297-3902***Shipping Address***26129 Calvary Lane NE, Suite 200***Kingston, WA 98346 USA***Fax: 360-297-3903". || The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". || The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". || The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***".
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Pro Trainers' Choice Company, PO BOX 27, 26129 Calvary Lane NE, Suite 200, Kingston WA 98346
  • Source
    USFDA