BEUDAMED
    FDA Enforcement Class II Terminated

    Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH; CB062313, SYNTEL BILIARY 6F-23CM CATH. Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.

    Recall: Z-2447-2012 · Reported October 3, 2012

    Enforcement

    Recall Number
    Z-2447-2012
    Event ID
    63100
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Applied Medical Resources Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 3, 2012
    Initiation Date
    August 9, 2012
    Classification Date
    September 25, 2012
    Termination Date
    March 22, 2013
    Address
    22872 Avenida Empresa # 3, N/A, Rancho Santa Margarita, CA, 92688-2650, United States

    Description

    Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH; CB062313, SYNTEL BILIARY 6F-23CM CATH. Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.

    Reason

    Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

    Code Info

    Model Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852, 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.

    Quantity

    40,238 units for all products in Recall Event