BEUDAMED
    FDA Recall Terminated

    Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal layers of the small intestine of healthy sheep, or from the serosal layers of the small intestine of healthy cattle. Fast absorbing surgical gut sutures are sterile and elecit only a slight to minimal tissue reaction during absorption.

    Recall: Z-1839-2015 · Initiated May 8, 2015

    Recall

    Recall Number
    Z-1839-2015
    Event Number
    71373
    Firm
    Ethicon, Inc. US
    FEI Number
    2210968
    Product Code
    GAL
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 8, 2015
    Posted
    June 25, 2015
    Terminated
    June 6, 2017
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal layers of the small intestine of healthy sheep, or from the serosal layers of the small intestine of healthy cattle. Fast absorbing surgical gut sutures are sterile and elecit only a slight to minimal tissue reaction during absorption.

    Reason

    Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.

    Action

    Ethicon initiated this voluntary recall by sending an Urgent: Medical Device Recall (Removal) Letter/Business Reply Form (BRF) dated May 8, 2015 to their affected customers via UPS. Stericycle will be handling returns. The letters identified the affected device and the reason for the recall. Customers were asked to examine their inventory immediately to determine if they had affected devices on hand. If so, they are to remove the affected product and communicate the issue to any necessary personnel. Customers with questions were advised to contact their local sales representative or call the Customer Support Center at 1-877-384-4266. For questions regarding this recall call 908-218-0707.

    Distribution

    Worldwide Distribution -- US (nationwide) and Canada.

    Quantity

    1,922 units