BEUDAMED
    FDA Recall Terminated

    Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K

    Recall: Z-0663-03 · Initiated February 21, 2003

    Recall

    Recall Number
    Z-0663-03
    Event Number
    25680
    Firm
    Curon Medical Inc
    FEI Number
    3007729452
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 21, 2003
    Posted
    March 20, 2003
    Terminated
    April 21, 2003
    Address
    735 Palomar Avenue, Sunnyvale, CA, 94086

    Description

    Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K

    Reason

    Catheter shaft has potential to crack during use.

    Action

    On 2/21/03 the firm initiated the recall and its notification was via letters to inform its consignees about the problem with its catheters. It requests immediate discontinuance of all product with certain lot numbers.

    Distribution

    Product was released for distribution to 52 direct accounts nationwide including 1 VA Medical Center, Endoscopy Dept., 150 S. Huntington Ave., Boston, MA 02130, ATTN: Dr. Hiroshi Mashimo, ph#: 617-363-5640.