BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0833-2011 · Initiated November 8, 2010

    Recall

    Recall Number
    Z-0833-2011
    Event Number
    57196
    Firm
    Ohio Medical Corporation
    FEI Number
    1419185
    Product Code
    BTA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 8, 2010
    Posted
    December 29, 2010
    Terminated
    March 16, 2012
    Address
    1111 Lakeside Dr, Gurnee, IL, 60031

    Description

    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.

    Reason

    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: [email protected], or mail to: Ohio Medical Corproation Quality Assurance 1111 Lakeside Drive Gurnee, Illinois 60031. For questions regarding this recall call 847-855-6270.

    Distribution

    Worldwide Distribution - USA nationwide, Puerto Rico, and the coutries of Canada, Israel, Jordan, Kenya, Kuwait, Saudi Arabia, Taiwan, Thailand and Vietnam.

    Quantity

    4,183 units