BEUDAMED
    FDA Enforcement Class II Terminated

    BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿ injection site to provide a pathway for IV fluid administration.

    Recall: Z-0772-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0772-2014
    Event ID
    67098
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2014
    Initiation Date
    November 26, 2013
    Classification Date
    January 15, 2014
    Termination Date
    May 6, 2016
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿ injection site to provide a pathway for IV fluid administration.

    Reason

    BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product sterility.

    Code Info

    Marketing Status: Class II, 510K # K011858 Device Listing Number: D043644 Lot number 3021392

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada and Japan.

    Quantity

    268,500 products