Events

Rappel de Device Recall Care E Vac 3 Portable Suction

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ohio Medical Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    57196
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0833-2011
  • Date de mise en oeuvre de l'événement
    2010-11-08
  • Date de publication de l'événement
    2010-12-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95575
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Pump, portable, aspiration (manual or powered) - Product Code BTA
  • Cause
    The d-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened.
  • Action
    Ohio Medical sent Urgent Medical Device Correction Notification letters dated November 4, 2010, to all affected customers on November 8, 2010. The letters identified the product, the problems, and the action to be taken by the customer. Customers were instructed to take the affected product out of service, remove diode 14, and replace the foot screw contained therein. Customers were instructed to visit the micro-sites established for these repair procedures for step-by-step instructions on performing the repairs. Accounts with questions after viewing the video demonstration were directed to the Ohio Medical technical assistance line at 224-430-1522. Customers were asked to complete the attached Customer Acknowledgment Form and return the form to the Quality Assurance Department at (fax) 1.847.855.6304, or e-mail to: Complaints@OhioMedical.com, or mail to: Ohio Medical Corproation Quality Assurance 1111 Lakeside Drive Gurnee, Illinois 60031. For questions regarding this recall call 847-855-6270.

Device

Device Recall Care E Vac 3 Portable Suction
  • Modèle / numéro de série
    Model 758000; Diode only: serial numbers CDF00000001 thru CDG00001052;  Screw only: serial numbers CDJ00000745 thru CDK00000667 Diode & replacement screw: serial numbers CDG00001053 thru CDJ00000744
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA nationwide, Puerto Rico, and the coutries of Canada, Israel, Jordan, Kenya, Kuwait, Saudi Arabia, Taiwan, Thailand and Vietnam.
  • Description du dispositif
    Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 758000 || The device is a portable aspirator to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient.
  • Manufacturer
    Ohio Medical Corporation

Manufacturer

Ohio Medical Corporation
  • Adresse du fabricant
    Ohio Medical Corporation, 1111 Lakeside Dr, Gurnee IL 60031
  • Source
    USFDA