BEUDAMED
    FDA Enforcement Class II Terminated

    Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space.

    Recall: Z-1544-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1544-2015
    Event ID
    70873
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp. d.b.a. Integra Pain Management
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2015
    Initiation Date
    March 30, 2015
    Classification Date
    April 28, 2015
    Termination Date
    June 24, 2015
    Address
    3498 West 2400 South #1050, Salt Lake City, UT, 84119, United States

    Description

    Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space.

    Reason

    A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.

    Code Info

    Lot No. W1412086, Exp DEC-2017.

    Distribution

    Nationwide Distribution.

    Quantity

    90 Tuohy needles (9 cases of 10 each)