BEUDAMED
    FDA Enforcement Class II Terminated

    CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"

    Recall: Z-0099-2015 · Reported October 29, 2014

    Enforcement

    Recall Number
    Z-0099-2015
    Event ID
    66541
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intra Pump Infusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 29, 2014
    Initiation Date
    October 18, 2013
    Classification Date
    October 20, 2014
    Termination Date
    February 1, 2016
    Address
    920 Minters Chapel Rd Ste 200, Grapevine, TX, 76051-1302, United States

    Description

    CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"

    Reason

    Product has the potential to have a clear debris on the tip of the needle.

    Code Info

    Product Code CRN20, lot numbers 14N02, 15E01, 15A02

    Distribution

    Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.

    Quantity

    25,440 pieces