BEUDAMED
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    Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 29, 2012

    Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 22, 2012

    Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 29, 2012

    Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 15, 2012

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NJ4303 (Reorder No. 21-0426-01) described as 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 Luer-Activated Valve injenction Sites Burette set.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number AK2304 (Reorder No. 21-0308-01) 118 inch length/300 cm, 19ml priming volume, 60 drops/ml, 3 standard injection sites and 0.22 micron air-eliminating filter.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Baxter Interlink System Minivolume Extension Set, product code 1C8290; An Rx sterile, nonpyrogenic fluid pathway, 11.0'', 0.86 mL Vol., with 2 injection sites and male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FPA·December 15, 2005

    Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8739; An Rx sterile, nonpyrogenic fluid pathway, 8.0'', 0.6 mL Vol., with Luer Activated Valve for IV Access and male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FPA·December 15, 2005

    Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer lock adapter; for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; Baxter Healthcare, Deerfield, IL 60015; product code 2C7553

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FPA·February 16, 2007

    LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12163-01

    FDA Recall
    Terminated ·Hospira Inc.·Product code FPA·December 20, 2006

    IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve and Spin-Lock Connector, Catalog # 352049. For use with Secondary Container.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·March 27, 2009

    Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and Spin-Lock Connector, Catalog # 352520. For use with the Horizon NXT Pump, and OutLook Safety Infusion System.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·March 27, 2009

    Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports and OPTION-LOK, 15 drops/mL; a sterile Rx single patient device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160080401, list number 16008-01.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FPA·November 24, 2009

    Outlook Pump Set w/150 ml Burette w/15um Filter & Safeline Inj Site, Check Valve, 2 Safeline Inj Sites, 120 in NF3115M

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

    Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, 1.2um Filter, Spin Lock Connector, 120 in US3112F

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

    Outlook Pump IV Set w/Universal Spike, Check Valve, 4 Safeline Inj Sites, B/C Valve, 3 N/C Valves Stopcock, 138 in NF1501M3HP

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

    Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj Sites, Spin Lock Con & Pressure Limited Check Valve, 127 in

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

    MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009

    CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.

    FDA Recall
    Terminated ·Carefusion 303 Inc 3750 Torrey View Ct San Diego CA 92130-2622·Product code FPA·December 20, 2012

    96-8366 Drip Chambers, Convertible with Pierce Pin .138 Assembly; Abbott, Ashland, Ohio 44805; 650 drip chambers per case; Abbott Commodity 968366, Ashland Product #85-55960

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