BEUDAMED
    FDA Recall Terminated

    Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.

    Recall: Z-2995-2018 · Initiated August 14, 2018

    Recall

    Recall Number
    Z-2995-2018
    Event Number
    80785
    Firm
    Ohio Medical Corporation
    FEI Number
    1419185
    Product Code
    BTA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 14, 2018
    Posted
    September 7, 2018
    Terminated
    December 15, 2020
    Address
    1111 Lakeside Dr, Gurnee, IL, 60031-2489

    Description

    Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.

    Reason

    The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power.

    Action

    The firm, Ohio Medical, sent an "URGENT MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated 8/7/2018 to its customers on 8/14/2018. The letter described the product, problem and actions to be taken. The customers were instructed to take the affected care-e-vac3 units out of service and follow the instructions, site: https://www.ohiomedical.com/4897450, provided with this notification to change the orientation of the battery; If, upon opening the device, you identify damage to wiring, please contact Ohio Medical Customer Service at 866.549.6446 or email to [email protected] for additional instructions to replace the wiring harness; and complete the attached Customer Acknowledgement Form and return it to our Quality Assurance Department at 847/855-6304 (fax), email to: [email protected], or mail in the envelope provided to: Ohio Medical LLC, ATTN: Quality Assurance Department, 1111 Lakeside Drive, Gurnee, IL 60031. Please direct questions to Sr. Director, QA/RA at 847-855-6326 or email: [email protected].

    Distribution

    US Nationwide Distribution and internationally to countries: Canada, Saudi Arabia, and United Arab Emirates.

    Quantity

    1443 units