BEUDAMED
    FDA Enforcement Class III Terminated

    Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.

    Recall: Z-0899-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0899-2018
    Event ID
    79199
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Degania Silicone, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 14, 2018
    Initiation Date
    October 3, 2017
    Classification Date
    March 5, 2018
    Termination Date
    October 21, 2020
    Address
    Degania Bet, N/A, Dganya Bet, N/A, N/A, Israel

    Description

    Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.

    Reason

    Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.

    Code Info

    Lot No P1607442.

    Distribution

    US Distribution to Puerto Rico.

    Quantity

    4,000 units