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    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·August 26, 2015

    Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.

    FDA Enforcement
    Class II ·Terminated·Draeger Medical, Inc.·March 20, 2013

    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·July 13, 2015

    Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring Solution Networked solution/system used to monitor patients' vital signs and therapy, control alarms, review Web-based diagnostic images, access patient records, and scale up functionality based on patient acuity level.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code MHX·October 18, 2011

    Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code MHX·December 13, 2012

    Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professsionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.

    FDA Recall
    Terminated ·Draegar Medical Systems, Inc.·Product code MHX·February 21, 2018

    Draeger Infinity Acute Care System Monitoring Solution

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code MHX·December 10, 2013

    Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professsionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.

    FDA Enforcement
    Class II ·Terminated·Draegar Medical Systems, Inc.·April 25, 2018

    Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722

    FDA Recall
    Terminated ·Draegar Medical Systems, Inc.·Product code MHX·June 6, 2017

    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

    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