Events

Recall of Device Recall CIVCO Medical Solutions

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Med Tec 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
    69997
  • Event Risk Class
    Class 2
  • Event Number
    Z-0990-2015
  • Event Initiated Date
    2014-12-11
  • Event Date Posted
    2015-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132168
  • 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
    Restraint, protective - Product Code FMQ
  • Reason
    The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
  • Action
    The firm sent e-mailed Field Safety Notice letters and contacted customers via phone on December 11, 2014, informing customers of the issue with the product. Customers were advised they may accept the product as is or request a replacement. A response form was enclosed for consignees to indicate the status of the product. Please contact a CIVCO insides sales representative for additional assistance. You may reach your representative by calling CIVCO Medical Solutions, Radiation Oncology, at 800-842-8688 or 712-737- 8688 between 8:00AM and 5:00PM CST.

Device

Device Recall CIVCO Medical Solutions
  • Model / Serial
    Lot: M612690 REF: 20SR03
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.
  • Product Description
    Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx || The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
  • Manufacturer
    Med Tec Inc

Manufacturer

Med Tec Inc
  • Manufacturer Address
    Med Tec Inc, 1401 8th St SE, PO Box 320, Orange City IA 51041-7463
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA