Events

Recall of Device Recall CIVCO Shoulder Retractors

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
    71935
  • Event Risk Class
    Class 2
  • Event Number
    Z-2763-2015
  • Event Initiated Date
    2015-08-19
  • Event Date Posted
    2015-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139409
  • 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 wrist straps used for positioning the patient are too long.
  • Action
    Med Tec Inc sent an Urgent Field Correction Notice dated August 18, 2015, via e-mail on August 19, 2015, and made phone calls on August 19, 2015, to all affected customers requesting return of the product. Customers were instructed to forward a copy of the notification letter to all customers who have received the product. Customers with questions were instructed to reach their representative by calling CIVCO Medical Solutions, adiation Oncology, at 800-842-8688 or 319-248-8688 between 8:00AM and 5:00PM CST. For questions regarding this recall call319-248-6502.

Device

Device Recall CIVCO Shoulder Retractors
  • Model / Serial
    Lot numbers M765570 and M784310.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including NE, SC, and KS. Foreign distribution was made to Australia, China, Venezuela, Spain, Turkey, and Hong Kong
  • Product Description
    CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. || For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.
  • 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