BEUDAMED
    FDA Recall Terminated

    Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.

    Recall: Z-0830-2011 · Initiated August 20, 2009

    Recall

    Recall Number
    Z-0830-2011
    Event Number
    53183
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    FAT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 20, 2009
    Posted
    December 28, 2010
    Terminated
    January 3, 2011
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.

    Reason

    The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.

    Action

    Stryker issued Urgent Product Recall letters dated August 20, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the affected product to Styrker.

    Distribution

    Worldwide Distribution: USA in the states of: Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming, and the countries/region of Australia, Canada, Scandinavia, Italy, and Switzerland.

    Quantity

    2985 units