BEUDAMED
    FDA Recall 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 · Initiated March 30, 2015

    Recall

    Recall Number
    Z-1544-2015
    Event Number
    70873
    Firm
    Integra LifeSciences Corp. d.b.a. Integra Pain Management
    FEI Number
    1000138491
    Product Code
    BSP
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 30, 2015
    Posted
    April 29, 2015
    Terminated
    June 24, 2015
    Address
    3498 West 2400 South, # 1050, Salt Lake City, UT, 84119

    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.

    Action

    US Consignees were notified by an Urgent: Voluntary Medical Device Recall letter on 3/30/15 delivered by traceable courier service. The letter identified the affected product and explained the reason for the recall. Customers were asked to review their inventory, identify affected products, and immediately stop use and remove them from service. Customers are to complete the attached form and return via mail or fax. Upon receipt of the form, Customer Service will provide an RMA number and directions for returning the affected products to the firm. Customers should contact Customer Service at 1-800-241-2210 with any questions regarding the instructions.

    Distribution

    Nationwide Distribution.

    Quantity

    90 Tuohy needles (9 cases of 10 each)