BEUDAMED
    FDA Recall Terminated

    Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300, Bard Access Systems, Inc., Salt Lake City, UT 84116. The Groshong is a family of single and dual -lumen peripherally placed mid-line and central catheters made from specially formulated and processed medical grade materials, in a tray with accessories for reliable long (greater than 30 days) or short term (less than 30 days) vascular access.

    Recall: Z-0865-2011 · Initiated December 10, 2010

    Recall

    Recall Number
    Z-0865-2011
    Event Number
    57457
    Firm
    Bard Access Systems
    FEI Number
    3006260740
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 10, 2010
    Posted
    January 6, 2011
    Terminated
    May 4, 2011
    Address
    605 North 5600, West Salt Lake City, UT, 84116-3738

    Description

    Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300, Bard Access Systems, Inc., Salt Lake City, UT 84116. The Groshong is a family of single and dual -lumen peripherally placed mid-line and central catheters made from specially formulated and processed medical grade materials, in a tray with accessories for reliable long (greater than 30 days) or short term (less than 30 days) vascular access.

    Reason

    Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits.

    Action

    BARD Access Systems sent an URGENT: GROSHON* 3 FR SINGLE-LUMEN PICC INTERMEDIATE TRAY WITH SAFETY INTRODUCER RECALL letter dated December 10, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the product subject to recall, discontinue use, and cease further distribution of any the affected product. If the product was further distributed, those customers were to be notified immediately with a copy of the recall notification letter. Any remaining product was to be returned to Bard. For information regarding this recall call 800-290-1689.

    Distribution

    Nationwide Distribution including AL, AZ, CA, GA, IA, MN, MO, NE, NJ, NY, OH, OR, SD, and WI.

    Quantity

    195 units