BEUDAMED
    FDA Recall Terminated

    Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.

    Recall: Z-2448-2012 · Initiated August 9, 2012

    Recall

    Recall Number
    Z-2448-2012
    Event Number
    63100
    Firm
    Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa
    FEI Number
    2027111
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    August 9, 2012
    Posted
    September 25, 2012
    Terminated
    March 22, 2013
    Address
    Margarita, CA, 92688-2650

    Description

    Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.

    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.

    Action

    Applied Medical sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to complete the attached Recall Notification Confirmation Form and to return it to the firm via e-mail to [email protected] or fax to (949) 713-8832. For product return questions, customers were instructed to contact Sales Operations Administrator at (949) 713-8652.For questions regarding this recall contact the firm at (949) 713-8041.

    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