BEUDAMED
    FDA Recall Terminated

    Juxta-Lite compression wrap Large Short 28cm Length with Separate Medium AFW Catalog 23135017

    Recall: Z-1697-2010 · Initiated April 20, 2010

    Recall

    Recall Number
    Z-1697-2010
    Event Number
    55529
    Firm
    Circaid Medical Products Inc
    FEI Number
    2243150
    Product Code
    MDR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 20, 2010
    Posted
    May 27, 2010
    Terminated
    January 6, 2011
    Address
    9323 Chesapeake Dr, Ste B1/B2, San Diego, CA, 92123

    Description

    Juxta-Lite compression wrap Large Short 28cm Length with Separate Medium AFW Catalog 23135017

    Reason

    Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level

    Action

    CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided. this listing for product returns.

    Distribution

    Worldwide distribution: USA, Japan, Canada, Netherlands

    Quantity

    372 total, all sizes