BEUDAMED
    FDA Recall Terminated

    Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyrogenic. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.

    Recall: Z-0079-2012 · Initiated September 9, 2011

    Recall

    Recall Number
    Z-0079-2012
    Event Number
    59948
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DXS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 9, 2011
    Posted
    October 20, 2011
    Terminated
    October 11, 2012
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyrogenic. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.

    Reason

    Pressure Display Set (models 61000, 61006, 62000, 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedures up to 6 hours). Use beyond 6 hours may result in air leakage in the system resulting in a pressure reading that is not representative of the actual line pressure.

    Action

    Medtronic Perfusion Systems, sent an "Urgent Medical Device Notification letter dated September 9, 2011, via UPS 2-day delivery to all affected customers. The letter identified the affected devices, described the issues, and the actions needed to be taken. The letter indicates when approved, the updated Directions for Use for the Pressure Display Box and Pressure Display Sets will be sent to customers. Customers were asked to complete the Customer Confirmation Certificate and return to Medtronic per the instructions on the form. The letter states that if the recalled products have been further distributed, forward this letter immediately to all customers who received the affected products, and gather proof of notification. For further questions concerning this notification, contact Medtronic Cardiovascular Technical Support at 877-526-7890 or Medtronic Sales Representative.

    Distribution

    Worldwide Distribution - USA (nationwide) including Puerto Rico, and Virgin Islands (U.S.) and the countries of: Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Yemen.

    Quantity

    74,804