BEUDAMED
    FDA Recall Terminated

    ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Sorenson Medical, Inc., West Jordan, Utah.

    Recall: Z-0186-2007 · Initiated October 10, 2006

    Recall

    Recall Number
    Z-0186-2007
    Event Number
    36505
    Firm
    Sorenson Medical, Inc.
    FEI Number
    1000117099
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 10, 2006
    Posted
    November 16, 2006
    Terminated
    May 26, 2011
    Address
    1375 W 8040 S, West Jordan, UT, 84088-8320

    Description

    ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Sorenson Medical, Inc., West Jordan, Utah.

    Reason

    Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.

    Action

    Consignees were notified by letter on 10/10-11/2006 and told to immediately discontinue use/quarantine all affected cassettes. .

    Distribution

    Worldwide, including USA, Belgium, France, Germany, Italy, Singapore, Venezuela.

    Quantity

    30,697 units