BEUDAMED
    FDA Recall Terminated

    Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.

    Recall: Z-0359-06 · Initiated December 13, 2005

    Recall

    Recall Number
    Z-0359-06
    Event Number
    34222
    Firm
    Sandhill Scientific, Inc
    FEI Number
    2023374
    Product Code
    FAP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 13, 2005
    Posted
    January 6, 2006
    Terminated
    May 15, 2006
    Address
    9150 Commerce Center Cir, Ste 500, Highlands Ranch, CO, 80129-1563

    Description

    Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.

    Reason

    Labeling does not indicate that the product contains latex.

    Action

    All consignees were notified by letter on 12/3/05. Canadian consignees were re-notified on December 14, 2005 by letter.

    Distribution

    Distributed nationwide including PR. Military distibution in MD and TX. Veteran Affairs facilities located in AR, CO, CT, HI, and NC. Foreign distribution includesTaiwan, Saudi Arabia, England, Malaysia, Korea, Chile, Venequela, China, and Brazil.

    Quantity

    2358 Probes