BEUDAMED
    FDA Enforcement Class II Terminated

    Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL FLEX syringes, 2 small spikes, patient t-connector tubing & prime tube.

    Recall: Z-0483-2021 · Reported December 2, 2020

    Enforcement

    Recall Number
    Z-0483-2021
    Event ID
    86619
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bayer Medical Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 2, 2020
    Initiation Date
    October 5, 2020
    Classification Date
    November 23, 2020
    Termination Date
    March 19, 2021
    Address
    1 Bayer Dr, N/A, Indianola, PA, 15051-9702, United States

    Description

    Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL FLEX syringes, 2 small spikes, patient t-connector tubing & prime tube.

    Reason

    Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.

    Code Info

    Catalog/REF Number: FLEXD-150-SCS Material Number: 87078817 Lot Numbers: 8584324, 8586383, 8586384, 8586385, 8586386, 8586388 UDI Numbers: (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 Catalog/REF Number: FLEXD-150-SPK Material Number: 85020218 Lot Number: 8585234 UDI Numbers: (01)00616258010656(11)200720(17)240720(10)8585234

    Distribution

    Distributed to healthcare facilities nationwide throughout the US.

    Quantity

    92,420 units