KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608. Made in U.S.A.
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Carestream Health, Inc. - KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500 - Class 2 Recall
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Philips Medical Systems (Cleveland) Inc - Brilliance iCT and iCT SP - Class 2 Recall
Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
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Biomerieux France Chemin De L'Or - ZYM B Reagent (REF 70493) - Class 2 Recall
ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.
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DeRoyal Industries Inc - DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt - Class 2 Recall
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
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DeRoyal Industries Inc - DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps - Class 2 Recall
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
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DeRoyal Industries Inc - Aquarius (TM) TEMPERATURE THERAPY - Class 2 Recall
Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.
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Biomerieux France Chemin De L'Or - API NH (REF 10400) - Class 2 Recall
API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.
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DeRoyal Industries Inc - DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket - Class 2 Recall
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
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Biomerieux France Chemin De L'Or - API Listeria (REF 10300)) - Class 2 Recall
API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.
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Philips Healthcare - Thermal Regulating System - Class 2 Recall
InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908
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DeRoyal Industries Inc - DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps - Class 2 Recall
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
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DeRoyal Industries Inc - DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket - Class 2 Recall
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
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GE Healthcare, LLC - GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems - Class 2 Recall
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
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Philips Medical Systems (Cleveland) Inc - Brilliance iCT and Brilliance iCT SP - Class 2 Recall
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories
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Symmetry Medical/SSI - Symmetry and CODMAN(R) brands, QUADLOCK (TM) Sterilization Container - Class 2 Recall
Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8732, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8733, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8734, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8735, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8744, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8745, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8746, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8747, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8748, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Lid Grey Small 4 Latch, REF 50-8950, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Lid Yellow Small 4 Latch, REF 50-8951, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Lid Green Small 4 Latch, REF 50-8952, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Lid Blue Small 4 Latch, REF 50-8953, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Lid Red Small 4 Latch, REF 50-8954, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Lid Black Small 4 Latch, REF 50-8955, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Medium Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Medium Perforated Bottom, REF 50-8736, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Medium Perforated Bottom, REF 50-8737, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Medium Perforated Bottom, REF 50-8738, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive,
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Sorin Group Deutschland GmbH - CP5 centrifugal pump system - Class 2 Recall
CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
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Sorin Group Deutschland GmbH - Stockert S5 System I Sorin C5 System - Class 2 Recall
S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
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Stryker Howmedica Osteonics Corp. - Class 2 Recall
Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems
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Orthofix, Inc. - Class 2 Recall
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
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Focus Diagnostics Inc - Simplexa Flu A/B & RSV Direct assay - Class 2 Recall
Simplexa" Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.
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