BEUDAMED
    FDA Recall Terminated

    Direct Water feed Kit, Catalog#10373222

    Recall: Z-1661-2015 · Initiated March 5, 2015

    Recall

    Recall Number
    Z-1661-2015
    Event Number
    71022
    Firm
    Siemens Medical Solutions Diagnostics
    FEI Number
    1000122204
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 5, 2015
    Posted
    May 23, 2015
    Terminated
    January 16, 2018
    Address
    62 Flanders-Bartley Rd, Flanders, NJ, 07836-4715

    Description

    Direct Water feed Kit, Catalog#10373222

    Reason

    The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.

    Action

    Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.

    Distribution

    Worldwide Distribution.

    Quantity

    15 bottles