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    Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity.

    FDA Recall
    Terminated ·Espiner Medical Ltd Yeo Bank 3, Kenn Road Clevedon United Kingdom·Product code GCJ·June 20, 2018

    The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The system contains one (1) Sac and one (1) obturator in a sterile, ready -to -use, single- use procedure tray.

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code GCJ·August 3, 2010

    DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers.

    FDA Recall
    Terminated ·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code DWF·September 29, 2008

    Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code GEX·May 9, 2016

    Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase Cooled Laser Applicator System 10mm Tip; c. Part Number 9735561 Visualase Cooled Laser Applicator System 15mm Tip Product Usage: The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800 nm - 1060 nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images to determine relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code GEX·March 23, 2018

    Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

    FDA Recall
    Terminated ·SA3, LLC·Product code OLR·February 21, 2022

    RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.

    FDA Recall
    Terminated ·Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain·Product code IZL·July 13, 2015

    MobileDiagnost wDR motorized portable diagnostic X-ray systems.

    FDA Recall
    Terminated ·Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain·Product code IZL·August 6, 2014

    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

    GE Healthcare Definium 5000 / 5220493 X-Ray System

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAC·September 26, 2012

    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

    Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern

    FDA Recall
    Terminated ·Beekley Corporation·Product code JAC·July 9, 2012

    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