BEUDAMED
    FDA Enforcement Class II Terminated

    PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5ml Ampule 1.5% Lidocaine HCl with Epinephrine 1:200,000.

    Recall: Z-0278-2023 · Reported November 30, 2022

    Enforcement

    Recall Number
    Z-0278-2023
    Event ID
    91037
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pajunk Medical Systems, L.P.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 30, 2022
    Initiation Date
    October 10, 2022
    Classification Date
    November 23, 2022
    Termination Date
    January 17, 2024
    Address
    4575 Marconi Drive, N/A, Alpharetta, GA, 30005, United States

    Description

    PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5ml Ampule 1.5% Lidocaine HCl with Epinephrine 1:200,000.

    Reason

    The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.

    Code Info

    Lot 0001359, Exp. date 2024-04-01, UDI (01) 00858965006007(17)240401(10)0001859..

    Distribution

    US Nationwide distribution in the states of CA, NC, TN, PA, and TX.

    Quantity

    280 trays