BEUDAMED
    FDA Recall Terminated

    OSCOR ADELANTE BREEZEWAY 8F C120 S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    Recall: Z-0797-2017 · Initiated October 5, 2016

    Recall

    Recall Number
    Z-0797-2017
    Event Number
    75785
    Firm
    Oscor, Inc.
    FEI Number
    1035166
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 5, 2016
    Terminated
    July 26, 2019
    Address
    3816 Desoto Blvd, Palm Harbor, FL, 34683-1618

    Description

    OSCOR ADELANTE BREEZEWAY 8F C120 S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    Reason

    Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

    Action

    Oscor sent two(2) Product Recall notifications: -HOSPITALS: Immediately check your inventory to confirm that you do or do not have units from these lot(s) in your possession. Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage. Review, complete, sign and return the enclosed Acknowledgement Form attached in the letter, directly to Oscor Inc. at the fax number or e-mail on the form, for immediate replacement (as applicable). Who to call: Please call Oscor Inc. Customer Service Department at 727-937-2511 or email [email protected] Hours of operations: Monday to Friday from 8:30AM to 5:30PM Eastern Time. - DISTRIBUTORS: Immediately check your inventory to confirm that you do or do not have units from these lot(s) in your possession. Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage. Please pull a list of the hospitals (end user) impacted by the affected lots and retrieve inventory for replacement, if available. Review, complete, sign and return the enclosed Acknowledgement Form (Exhibit A) attached in this letter, directly to Oscor Inc. at the fax number or e-mail on the form, for immediate replacement (as applicable). Who to call: Please call Oscor Inc. Customer Service Department at 727-937-2511 or email [email protected] Hours of operation: Monday to Friday from 8:30AM to 5:30PM Eastern Standard Time.

    Distribution

    Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

    Quantity

    11