BEUDAMED
    FDA Recall 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 311291155 for epidural or caudal anesthesia

    Recall: Z-2068-2019 · Initiated June 18, 2019

    Recall

    Recall Number
    Z-2068-2019
    Event Number
    83247
    Firm
    Epimed International, Inc.
    FEI Number
    1316297
    Product Code
    BSO
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 18, 2019
    Address
    141 Sal Landrio Dr, Crossroads Business Park Johnstown, NY, 12095-3835

    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 311291155 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.

    Action

    On June 19, 2019 , the firm mailed a lot specific, medical device market correction letter, via USPS to consignees who received the affected product(s). The letter asked customers to do the following: 1. Please examine your inventory and quarantine any product subject to the recall immediately. 2. Once product has been Quarantined, please complete and return the response form as soon as possible. 3. Please contact EPIMED sales administrative assistance, Bobbi Harrington at (518) 725-0209 ext. 1200 or [email protected], so that immediate replacement or credit for the affected product can be arranged. 4. If you have any questions, please contact Mr. Kris Knapp at 1-800-866-3342 ext. 1305.

    Distribution

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

    Quantity

    200 kits