BEUDAMED
    FDA Recall Terminated

    Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straight or right angle, available with proximal end fittings for either 1/4 inch connector or male luer fitting, Model numbers 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804, 215805, 215806, 215807, 215810, 215811, 215812, 215813, 215814, 215815, 215816, and 215817.

    Recall: Z-1869-2009 · Initiated May 19, 2009

    Recall

    Recall Number
    Z-1869-2009
    Event Number
    52663
    Firm
    Maquet Cardiovascular
    FEI Number
    3000719698
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 19, 2009
    Posted
    August 31, 2009
    Terminated
    December 21, 2010
    Address
    170 Baytech Dr, San Jose, CA, 95134-2302

    Description

    Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straight or right angle, available with proximal end fittings for either 1/4 inch connector or male luer fitting, Model numbers 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804, 215805, 215806, 215807, 215810, 215811, 215812, 215813, 215814, 215815, 215816, and 215817.

    Reason

    Undeclared allergen: Products are missing the warning label declaring that the products contain natural rubber latex.

    Action

    Maquet Cardiovascular issued a notification letter to consignees on May 19, 2009.

    Distribution

    Nationwide distribution.

    Quantity

    2,226 devices