BEUDAMED
    FDA Enforcement Class II Terminated

    Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia

    Recall: Z-2069-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2069-2019
    Event ID
    83247
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Epimed International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2019
    Initiation Date
    June 18, 2019
    Classification Date
    July 24, 2019
    Address
    141 Sal Landrio Dr, Crossroads Business Park, Johnstown, NY, 12095-3835, United States

    Description

    Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia

    Reason

    Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.

    Code Info

    Lot 31129344 Exp: 2023-06-30

    Distribution

    Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico

    Quantity

    98 kits