BEUDAMED
    FDA Recall Terminated

    Modified Novy Cornual Cannulation Set with clear tip, G17558, REF J-NCS-504070, Cook OB/GYN.

    Recall: Z-1137-2010 · Initiated January 8, 2010

    Recall

    Recall Number
    Z-1137-2010
    Event Number
    54231
    Firm
    Cook Women'S Health
    FEI Number
    3005990734
    Product Code
    MOV
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 8, 2010
    Posted
    March 15, 2010
    Terminated
    December 10, 2010
    Address
    1100 W Morgan St, Spencer, IN, 47460-9426

    Description

    Modified Novy Cornual Cannulation Set with clear tip, G17558, REF J-NCS-504070, Cook OB/GYN.

    Reason

    The distal tip may separate from the catheter while the catheter is in the patient.

    Action

    Cook Women's Health sent Urgent Recall Notice letters dated 1/8/2010. Consignees were instructed to return product to the manufacturer for credit.

    Distribution

    USA, Ireland, China, Canada, India, Australia, Hong Kong.

    Quantity

    721 both products