BEUDAMED
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    Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021. Intended to aid in the fabrication of dental prosthetics, and be used as a accessory with endosseous dental implants.

    FDA Recall
    Terminated ·Straumann Manufacturing Inc.·Product code NDP·June 15, 2010

    Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only: 1050-110-ENG Outside US: 1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER, 1050-240-DUT, 1050-240-FRN, 1050-240-CZE, 1050-IIO-JPN. Provides perioperative autotransfusion ( salvaging and reinfusing red blood cells (RBC's) from blood shed from patients undergoing orthopedic surgery. The portable system is used in operating rooms to recycle blood lost during surgery and in the recovery room to recycle blood lost after surgery. It can be transported to the patient floor for postoperative salvage.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·April 29, 2011

    Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code FRN--·December 17, 2003

    Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software - Administrator REF 21-6275-51 RX only, Smiths Medical MD, Inc. St Paul, Minnesota 55112 USA

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FRN·August 14, 2007

    Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 - software version 11.3 d) list 20679 - Hospira MedNet Software e) list 20792 - Driver The Plum A+ dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield needleless protection systems makes the Plum A+ a convenient and cost-effective infusion system.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·September 16, 2011

    ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

    FDA Recall
    Terminated ·MOOG Medical Devices Group·Product code FRN·September 26, 2012

    SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FRN·June 10, 2013

    GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·February 18, 2014

    Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·January 24, 2014

    I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion Pumps; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 86 different sets listed in the code information section below.

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code FRN·June 9, 2003

    Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161and 2M8161R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·November 4, 2004

    Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·November 14, 2005

    Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·December 6, 2006

    Stryker PainPump base kit, 120 mL infusion kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-100.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

    Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-site catheter set, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-25.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

    Stryker PainPump, 5-day infusion kit, 120 mL infusion kit (0.83 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-110.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

    Stryker PainPump, two site infusion set, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-200.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

    Stryker PainPump2, 2-site tube set with 5.0" ExFen, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-200-50.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

    Stryker PainPump2 ExFen 5, 5" extended fenestration catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-500.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

    ***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

    FDA Recall
    Terminated ·Zevex International, Inc.·Product code FRN·January 24, 2011