BEUDAMED
    FDA Recall Terminated

    Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 USA

    Recall: Z-1213-2007 · Initiated June 18, 2007

    Recall

    Recall Number
    Z-1213-2007
    Event Number
    38306
    Firm
    Smiths Medical MD, Inc.
    FEI Number
    2183502
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 18, 2007
    Posted
    August 30, 2007
    Terminated
    February 10, 2011
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

    Description

    Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 USA

    Reason

    Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these Affected Cassettes have been used for delivering Flolan.

    Action

    All customers who have received the CADD Medication Cassette reservoirs have been sent the Product Recall Notification Letter on June 18, 2007 making them aware of the potential issue. Customers will be required to return the affected devices to Smiths Medical. All returned recall affected product will be quarantined and then destroyed. The consignees are to fill and fax "Attachment 1" form in regard to affected product inventory to Smiths Medical MD.

    Distribution

    Worldwide, including USA, Canada, Mexico, Sweden, Germany, Japan, Australia, Taiwan, Poland, Jordan, Czech Republic, Denmark, Paraguay, Hong Kong, Singapore, Argentina, Italy, Venezuela, Greece, Norway, Pakistan, Puerto Rico, Thailand, United Arab Emirates, Netherlands Antilles, Malaysia, Panama, Hungary, Saudi Arabia, Portugal, South Africa, Denmark, the Netherlands, France, United Kingdom, Great Britain, Spain, Finland, Guam, Virgin Islands, China, Israel, Austria, and Switzerland.

    Quantity

    8555 boxes