BEUDAMED
    FDA Recall Terminated

    Arterial Pressure Monitoring Tray, 2.5 Fr/ 2.5 cm Polyethylene Catheter,C-PMSY-250-HOPKINS, G44036, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    Recall: Z-1134-2011 · Initiated October 4, 2010

    Recall

    Recall Number
    Z-1134-2011
    Event Number
    57663
    Firm
    Cook, Inc.
    FEI Number
    1820334
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 4, 2010
    Posted
    February 23, 2011
    Terminated
    June 21, 2011
    Address
    750 Daniels Way, Bloomington, IN, 47404-9120

    Description

    Arterial Pressure Monitoring Tray, 2.5 Fr/ 2.5 cm Polyethylene Catheter,C-PMSY-250-HOPKINS, G44036, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    Reason

    Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection USP 5 mL fill in 6 mL flush syringes that have been recalled by Excelsior Medical. During a routine test for syringe sterility, a possible integrity failure wa

    Action

    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.

    Distribution

    Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

    Quantity

    51,473 total kits/trays