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    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics·September 26, 2018

    VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics·September 26, 2018

    FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for use in a variety of austere environments.

    FDA Recall
    Terminated ·Fort Defiance Industries, LLC·Product code FLE·May 24, 2018

    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGZ·July 11, 2018

    VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JFY·July 11, 2018

    ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.

    FDA Recall
    Terminated ·Phadia US Inc·Product code DHB·December 18, 2017

    ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.

    FDA Recall
    Terminated ·Phadia US Inc·Product code DHB·December 18, 2017

    Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·March 19, 2015

    Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 22, 2015

    BariAir AC-Powered Adjustable Hospital Beds

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IOQ·April 11, 2000

    Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·May 12, 2009

    BF-3C40 OES Bronchofiberscope, Model No. BF-3C40

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021

    EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 17, 2021

    Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US

    FDA Recall
    Terminated ·Prodimed Plastimed Division 3 Rue Louis Armand Le Plessis Bouchard France·Product code EOQ·May 27, 2020

    IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and deep tissue injury) and is recommended to be implemented in combination with clinical evaluation of risk factors and skin assessments made by a health care professional. This support surface is for use with human patients with existing or at risk of incurring pressure injuries. The patient must not exceed the safe working load as specified by the support surface. A healthcare professional should determine the use of this support surface by patients outside of the therapeutic weight range. The minimum patient age requirement for this support surface is two years. IsoFlex LAL shall be used with a support surface cover at all times. The support surface cover can interact with all external skin. This support surface is for use by patients in an acute care setting. This may include critical care, step down, progressive care, med/surg, subacute care, and post anesthesia care unit (PACU), or other locations as prescribed by a physician. Operators of this support surface include healthcare professionals (such as nurses, nurse aids, or doctors). IsoFlex LAL support surface is not intended to: be used in a home health environment setting be used as a sterile product include a measuring function be used with a patient less than two years of age Stryker promotes the clinical assessment of each patient and appropriate usage by the operator.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code IOQ·August 13, 2018

    Bronchofiberscope BF-40

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018

    Bronchovideoscope BF-Q180-AC

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018

    Bronchovideoscope F-1TQ180

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018

    Ultrasonic Bronchoscope BF-UC160F-OL8

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018

    Bronchofiberscope BF-XP60

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018