Events

Recall of Device Recall Fernotrac

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ferno-Washington 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
    73641
  • Event Risk Class
    Class 2
  • Event Number
    Z-1603-2016
  • Event Initiated Date
    2016-03-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144675
  • 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
    Stretcher, patient restraint - Product Code NZD
  • Reason
    On march 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. the firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. the packaging labeled adult contained a pediatric splint strap and the packaging labeled pediatric cont.
  • Action
    Ferno-Washington, Inc , has contacted all customers via telephone on March 10, 2016. All products will be replaced with new products. For further questions, please call: (937) 283-2885.

Device

Device Recall Fernotrac
  • Model / Serial
    Strap Kit Pediatric Model 443
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this recall. There is one Canadian account for this recall. There are no Mexican accounts for this recall. and to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR and AUSTRALIA..
  • Product Description
    Poly-bags containing splint strap labeled with "Pediatric" sticker. || Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.
  • Manufacturer
    Ferno-Washington Inc

Manufacturer

Ferno-Washington Inc
  • Manufacturer Address
    Ferno-Washington Inc, 70 Weil Way, Wilmington OH 45177-9371
  • Manufacturer Parent Company (2017)
    Ferno-Washington Inc.
  • Source
    USFDA