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    Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device, .

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code KPS·May 31, 2004

    Gravity Compensating Accessory; High Pressure Range, Sterile, Single Use, Rx only. CSF shunt accessory. Manufacturer: Integra Neuro Sciences Implants, SA, Cedex, France; distributed by: Integra NeuroSciences, Plainsboro, NJ 08536 The GCA is an implantable device designed to be used in conjunction with implanted systems which shunt cerebrospinal fluid CSF from the cerebral ventricles to an appropriate drainage site.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code JXG·October 3, 2008

    MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies : Multiple myeloma oncogene-1 (MUM-1) is a protein encoded by MUM-1 gene. MUM-1 protein is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B-cells located in the light zone. MUM-1 [BC5] labels MUM-1protein in centrocytes and their progeny, plasma cells, activated T-cells and a wide spectrum of hematolymphoid neoplasms derived from these cells. MUM-1 has been reported to play an important role in mediating B-cell activation and differentiation.

    FDA Recall
    Terminated ·Biocare Medical Llc·Product code NJT·December 12, 2014

    ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Sendx Medical Inc·Product code CHL·February 20, 2009

    ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CGZ·June 10, 2004

    CORE Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for

    FDA Recall
    Terminated ·ConMed Corporation·Product code GAZ·June 27, 2016

    VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019

    Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length: 3.6 m (12 ft.); Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085 USA, Made in Mexico; catalog N712 and NEX712 (European label)

    FDA Recall
    Terminated ·Cardinal Health·Product code GAZ·August 16, 2010

    Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device and also includes a male connector that can be used for devices designed with female connectors, This product is sterile, non-conductive and latex free.

    FDA Recall
    Terminated ·Medtronic Minimally Invasive Therapies Group·Product code GAZ·October 24, 2017

    Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CGZ·August 28, 2018

    Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Mentor Texas, LP, Irving, TX 75038 (BD 60 mL Luer-Lok syringe manufactured by Becton Dickinson, Franklin Lakes, NJ 07417).

    FDA Recall
    Terminated ·Mentor Texas, Inc·Product code GAZ·August 22, 2008

    Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16"), Length: 1.8 m (6 ft.); Sterile, for single use only, 50 tubes per case; Cardinal Health, McGaw Park, IL 60085 USA, Made in Mexico; catalog N56A and NEX56A (European label)

    FDA Recall
    Terminated ·Cardinal Health·Product code GAZ·August 16, 2010

    VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019

    OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.

    FDA Recall
    Terminated ·OPTI Medical Systems, Inc·Product code CGZ·April 20, 2009

    Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16"), Length: 3.6 m (12 ft.); Sterile, for single use only, 50 tubes per case; Cardinal Health, McGaw Park, IL 60085 USA, Made in Mexico; catalog N512 and NEX512 (European label)

    FDA Recall
    Terminated ·Cardinal Health·Product code GAZ·August 16, 2010

    Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CGZ·September 26, 2007

    ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, v2.20DB, v2.60, v3.10, 3.11 and 3.12; distributed by Abbott Laboratories, Irving, TX. The Abbott ARCHITECT cSystem is designed to perform automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CGZ·May 23, 2008

    VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

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

    Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length: 1.8 m (6 ft.); Sterile, for single use only, 50 tubes per case; Cardinal Health, McGaw Park, IL 60085 USA, Made in Mexico; catalog N76A and NEX76A (European label)

    FDA Recall
    Terminated ·Cardinal Health·Product code GAZ·August 16, 2010

    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