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    APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc·Product code FGE·July 25, 2003

    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMI·May 31, 2017

    Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code KRB·October 5, 2018

    VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JRB·October 10, 2013

    Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.

    FDA Recall
    Terminated ·Pulsion Medical Inc·Product code KRB·November 4, 2014

    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code KRB·October 5, 2018

    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code KRB·October 5, 2018

    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.

    FDA Recall
    Terminated ·SALTER LABS·Product code CCK·May 30, 2012

    Emission Computed Tomography System

    FDA Recall
    Terminated ·Adac Labs·Product code KPS·June 21, 2004

    Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.

    FDA Recall
    Terminated ·SALTER LABS·Product code CCK·November 1, 2013

    GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271

    FDA Recall
    Terminated ·Abbott Labs·Product code FRN·May 11, 2004

    ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. Salter Labs Nasal Cannula (Adult), Salter Style with modified nasal prongs. w/7' O2 line and 7' CO2 line with male luer lock connector. Salter Labs 100 W. Sycamore Road, Arvin, CA 93203

    FDA Recall
    Terminated ·SALTER LABS·Product code CCK·December 7, 2011

    Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.

    FDA Recall
    Terminated ·Salter Labs·Product code BYG·June 25, 2014

    Salter Labs Bubble humidifier, with 6 PSI safety valve, 350cc, Latex Free; Single Patient use; used with supplemental oxygen therapy. Model Numbers 7600-0-50, E7600-0-50, NP7600-0-50 and special order patient kits that contain 7600 humidifiers. Patient kits have brand names of Salter Labs, AdvaCare; Allcare Medical; Memorial Home Services; Therapy Support Inc; Mendo-Lake Home Respiratory Services; MedAssurance Inc.; Abundant Home Care. Product Usage: Humidifier - single patient use. used with supplemental oxygen therapy.

    FDA Recall
    Terminated ·SALTER LABS·Product code BBT·October 21, 2011

    Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II), 250-500 per vial, Batch #: MM-090406 with CCII-0901. Maggot therapy is intended to debride serious non-healing (chronic) wounds, and the dressing intended to confine the maggots to the wound.

    FDA Recall
    Terminated ·Monarch Labs, LLC·Product code NQK·May 3, 2009

    Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.

    FDA Recall
    Terminated ·Wexford Labs Inc·Product code LRJ·September 10, 2013

    UltraVision Plus Detection System; Anti-Polyvalent, Alk-Phos/Fast Red (Ready to Use) Manufactured by: Lab Vision Corporation 46360 Fremont Blvd, Fremont, CA 94538 Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.

    FDA Recall
    Terminated ·Lab Vision Corporation·Product code NJT·January 11, 2012

    UltraVision Detection System; Anti-Polyvalent, Alk-Phos/BCIP/NBT (Ready to Use) Manufactured by: Lab Vision Corporation 46360 Fremont Blvd, Fremont, CA 94538 Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.

    FDA Recall
    Terminated ·Lab Vision Corporation·Product code NJT·January 11, 2012

    CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+). This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.

    FDA Recall
    Terminated ·Lab Vision Corporation·Product code NJT·January 18, 2016

    AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.

    FDA Recall
    Terminated ·Ansh Labs, LLC·Product code QKO·December 18, 2020