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    The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable infusion pumps (except Medtronic MiniMed pumps). The Model 8540 Catheter Access Port Kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump, infusion, implanted, programmable under product code LKK.

    FDA Recall
    Terminated ·Medtronic Inc, Neurological & Spinal Division·Product code LKK·July 23, 2004

    Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for refilling the Medtronic SynchroMed family of pumps. The 8561 kit contains a 1-20 ml ampule of 500 mcg/ml Baclofen injection along with a sterile refill kit tray and sterile drug preparation tray. Lioresal drug ampules contained witin Medtronic Lot N0016487 bear the primary manufacturer''s label and lot number 007J2583. The drug box is labeled with Lot 017H1925. Medtronic packages a manufacturer''s labeled ampule into a protective drug box. A lot number and drug lot expiration date are printed on the outside of the drug box. The filled and labeled drug box is placed inside a larger kit assembly that contains other components necessary to complete a pump refill. Only the large kit assembly (''Lioresal Refill Kit'') will display the Medtronic lot number (N0016487). The Model 8561 refill kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump infusion, implanted, programmable under product code LKK.

    FDA Recall
    Terminated ·Medtronic Inc, Neurological & Spinal Division·Product code LKK·November 19, 2004

    Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

    Medtronic SynchroMed EL Programmable Pump, Model 8627-10. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

    MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code LKK·November 10, 2015

    Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve, screened side catheter access port and suture loops. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

    Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve and screened side catheter access port. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

    Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-35. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 35 mL. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic IsoMed Constant-Flow Infusion Pump is part of the IsoMed Constant-Flow Infusion System designed to contain and administer parenteral drugs to a specific site. The components of the IsoMed Constant-Flow Infusion System include the pump, Medtronic catheter, catheter accessories, Medtronic Refill kit, and Medtronic catheter access port kit. IsoMed pumps are implantable devices that store and dispense drugs according to a constant flow rate set during the manufacturing process.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

    Model 8731SC Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·April 14, 2008

    Medtronic, Model 8870, Application Software Card is part of the SynchroMed II Drug Infusion System. The System includes the SynchroMed II implantable drug infusion pump 8637-20, 8637-40, N'Vision clinical programmer 8840 and the Software application card 8870. The SynchroMed II Infusion system contains and administers prescribed drugs to a specific site inside patient body. The SynchroMed II Pump is supplied in 20 ml and 40 ml reservoir sizes. In the United States, the SynchroMed II Pump is specifically approved for (indicated): The chronic epidural/intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain. The chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. The chronic intrathecal infusion of Prialt (preservative-free ziconotide sterile solution) for the management of severe chronic pain. The chronic intravascular infusion of floxuridine (FUDR) for the treatment of primary or metastatic cancer. The chronic intravascular infusion of methotrexate for the treatment of primary or metastatic cancer. Outside of the United States, the SynchroMed II Pump is indicated for the chronic infusion of drugs or fluids tested as compatible and listed in the product labeling for the specific geographies.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·March 12, 2012

    Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001

    FDA Recall
    Terminated ·Medtronic Inc.·Product code LKK·April 10, 2020

    Medtronic SynchroMed EL Programmable Pumps, Model 8626L-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

    Medtronic SynchroMed EL Programmable Pumps, Model 8627-18, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

    Medtronic SynchroMed EL Programmable Pumps, Models 8626-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

    IsoMed Refill Kit, Model 8553, Lot Number 60538731, is intended for use in refilling Medtronic IsoMed pumps. Contents: Two 22-gauge needles, extension tubing set with y-connector and clamp, Filter, 10-ml syringe, 60-ml lidded syringe, Fenestrated drape, Template; Use by Date May 10, 2009; Medtronic, Inc., Minneapolis, MN. Product is packaged in a sterile container.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·February 4, 2008

    Medtronic SynchroMed EL Implantable Infusion Pump, model 8626L-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve and suture loops. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

    Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve and screened side catheter access port. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

    Medtronic Sutureless Pump Connector Revision Kit, model 8578, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. The 8578 revision kit catheter connects to the catheter interface with a connector pin and strain-relief sleeve. The catheter interface connects to the pump with a sutureless pump connector. The 8578 revision kit is for use with 8709 and 8709SC catheters. Contents: Catheter interface with attached sutureless pump connector, catheter, connector pin and strain-relief sleeve. This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·August 27, 2009

    Medtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·February 26, 2014

    CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and Stopcock for pump refills. .

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code LKK·March 5, 2015