BEUDAMED
    FDA Enforcement Class II Terminated

    Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood.

    Recall: Z-0534-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0534-2018
    Event ID
    78968
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2018
    Initiation Date
    July 17, 2017
    Classification Date
    February 8, 2018
    Termination Date
    September 14, 2018
    Address
    1430 Marvin Griffin Rd, N/A, Augusta, GA, 30906-3851, United States

    Description

    Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood.

    Reason

    Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.

    Code Info

    Lot Numbers: 17E121362, 17E121262 UDI: 10884527016990; 20884527016997

    Distribution

    U.S., Gov Accts, and foreign countries: PA, PR, CO.

    Quantity

    33,280