BEUDAMED
    FDA Recall Terminated

    OR VANTEX 7FR 3L 16CM CVC ECVC6665

    Recall: Z-0100-2020 · Initiated April 24, 2019

    Recall

    Recall Number
    Z-0100-2020
    Event Number
    83584
    Firm
    Centurion Medical Products Corporation
    FEI Number
    3008403546
    Product Code
    OES
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 24, 2019
    Terminated
    April 3, 2020
    Address
    100 Centurion Way, Williamston, MI, 48895-9086

    Description

    OR VANTEX 7FR 3L 16CM CVC ECVC6665

    Reason

    Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

    Action

    On April 24, 2019, the firm notified customers who had received kits containing BD's MaxZero product. Customers were instructed to do the following: 1. Whether or not you have product in inventory, please complete and return the attached Centurion Accountability Record via email- [email protected] or via fax-517-546-3356. 2. Please share this communication with all users of the product within your organization, as directed in the BD letter. 3. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1- 800-332-1088); Mail: MedWatch, HF-2, FDA, 5600 Fisher's Lane, Rockville, MD 20852- 9787

    Distribution

    Nationwide domestic distribution.

    Quantity

    181965 total