BEUDAMED
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    Immunoradiometric assay.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JLW·November 28, 2012

    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JLW·November 28, 2012

    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JLW·November 28, 2012

    Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product number: 1650DE Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.

    FDA Recall
    Open, Classified ·Heartware·Product code DSQ·May 2, 2018

    Stryker CBCII 1/8in. Double Trocar with quick disconnect , sterile, Stryker Instuments, Kalamazoo, MI, REF225-28-85S1. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009

    Stryker CBCII ConstaVac Blood Conservation System w/Quick Disconnect and 3/16in. (4.8mm) PVC Drain, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-926. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009

    Haemonetics Cell Saver 5 Low Volume (12ml) Fast Pack with Filtered Reservoir List Number: 265F

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·December 17, 2002

    Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US Models Out-Side the US: 02050-UK, 02050-ES, 02050-IT, 02050-NL, 02050-GE, 02050-FR, 02050-JA The Haemonetics Cardiovascular Perioperative Autotransfusion System for Use (cardioPAT) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·July 27, 2011

    Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code CAC·November 8, 2006

    Zimmer H.A.S. Autotransfusion System, H.A.S. Replacement Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-050-05.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code CAC·January 29, 2008

    Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code CAC·November 19, 2013

    1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code CAC·March 26, 2015

    1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code CAC·March 26, 2015

    Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI W/S; (7)2050-000 DRAIN, OCEAN BRU W/AC,S

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code CAC·September 18, 2023

    JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019

    CS5/5+ Fastpacks, 125 mL, 20 Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019

    Stryker CBCII with Quick Disconnect, 3/16 in. Double Trocar and Reinfusion Labels, sterile Stryker Instruments, Kalamazoo, MI, REF 225-28-85S4. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009

    Stryker CBCII ConstaVac Blood conservation system, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28E. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009

    Stryker CBCII collection only pkg/6, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-S20. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009

    Stryker CBCII Double Trocar/Double Pouch Kit with 3/16in. (4.8mm) Drain, sterile, Stryker Instruments, Kalamazoo, MI REF 225-28-626S1. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009