BEUDAMED
    FDA Recall Terminated

    Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540, 220180560

    Recall: Z-1002-2011 · Initiated May 11, 2010

    Recall

    Recall Number
    Z-1002-2011
    Event Number
    56357
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    FAT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 11, 2010
    Posted
    February 1, 2011
    Terminated
    February 1, 2011
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540, 220180560

    Reason

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

    Action

    On 5/11/10, Stryker Endoscopy initiated the recall notification letters explaining the reason for the recall and requesting the product be returned.

    Distribution

    Nationwide and 3 foreign consignees (Canada, Singapore and Switzerland).

    Quantity

    4125