BEUDAMED
    FDA Recall 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 · Initiated October 10, 2022

    Recall

    Recall Number
    Z-0278-2023
    Event Number
    91037
    Firm
    Pajunk Medical Systems, L.P.
    FEI Number
    3004076349
    Product Code
    OGE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 10, 2022
    Posted
    November 23, 2022
    Terminated
    January 17, 2024
    Address
    4575 Marconi Drive, Alpharetta, GA, 30005

    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,.

    Action

    The recalling firm issued recall letters dated 10/10/2022 via email and overnight mail on 10/10/2022. The letter identified the product, the reason for recall and requested return of the affected lot as soon as possible. A return label was enclosed for return of product. A Customer Acknowledgment form was enclosed for return via email to report the quantity of product being returned. The form also asked the consignee if they remembered any used trays containing the 2ml ampule 0.75% Spinal Marcaine instead of the tray containing a 10ml ampule 0.9% Sodium Chloride. If the answer was yes, the consignee was to report whether the Marcaine was used and were there any adverse outcomes.

    Distribution

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

    Quantity

    280 trays