BEUDAMED
    FDA Enforcement Class II Terminated

    B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01

    Recall: Z-0509-2021 · Reported December 9, 2020

    Enforcement

    Recall Number
    Z-0509-2021
    Event ID
    86680
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Janus Trade Group
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 9, 2020
    Initiation Date
    March 23, 2020
    Classification Date
    November 30, 2020
    Termination Date
    May 20, 2021
    Address
    556 Industrial Way W, N/A, Eatontown, NJ, 07724-4236, United States

    Description

    B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01

    Reason

    Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.

    Code Info

    Lots 18L23G8271 17A20G8273 18M02G8315 16H16G8261 18K18G8244 17D08G8241 16H16G8261 15H25G8315 18G15A272 18G31G8316 18G31G8392 17H20G8391 18M02G8315 18M02G8315 18F29G8362 18D01G8273 17K08G8272 17K08G8273 17G10G8261 19A12G8272 19A12G8272 18H17G8272 18H17G8272 18F26G8303 18H04G8261 15F25G8395 17K27G8304 17C16G8304 17H02G8392 17F15G8302 17M10G8271 17M10G8273 17M15G8261 17C17G8302 17C18G8305 18M20G8271 18L29G8271 18K08G8263 18HI8G8243 18F25G8272 18F25G8272 17M11G8273 17H23G8272 17H23G8271 17H23G8271 18L23G8271 18L23G8271 17A20G8273 17A20G873 17A20G8273 17D08G8241 17D08G8241 17D08G8241 16N24G8303 16H30G8303 16H30G8304 16L0G8275 14N10G8274 16H16G8261

    Distribution

    US distribution to distributors located in CA, FL, IL, KS, NJ, NY, and TN.

    Quantity

    1365 cases (200 units/case)