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  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
Picis ED PulseCheckSoftware
  • Modelo / Serial
    Service Pack v5.0 L and M
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Picis ED PulseCheck-Software, transmission & storage, patient data || Service Pack v5.0 L and M || This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.
  • Manufacturer
    Picis Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Picis ED PulseCheckSoftware
Picis Anesthesia Manager
  • Modelo / Serial
    8.2 Service Pack 4 or higher.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- AZ, DE, FL, IL, NY, OH, PA, WI and WV.
  • Descripción del producto
    Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher || (Software, transmission & storage, patient data) || This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.
  • Manufacturer
    Picis Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Picis Anesthesia Manager
Amplilink Software v3.2
  • Modelo / Serial
    5666678001
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide (USA) Distribution
  • Descripción del producto
    Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
  • Manufacturer
    Roche Molecular Systems, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Amplilink Software v3.2
TX1 Tissue Removal System
  • Modelo / Serial
    Lot Numbers: 00312-07, 00713-06, 00912-01, 01813-02, 02413-04, 03113-02, 04213-01, 05113-01, 05113-02, 05512-03, 05713-03, 06313-05, 06512-08, 06513-02, 07213-04, 07912-06, 08212-07, 09412-03, 11412-06, 11612-05, 12912-04, 14512-07, 15312-03, 16412-07, 17412-01, 18712-06, 19812-13, 20212-03, 21412-03, 22212-03, 23412-06, 24112-06, 24212-04, 24912-13, 25712-01, 26912-01, 27712-05, 28512-03, 28912-03, 29612-01, 30512-02, 31112-05, 32112-03, 33112-01, 34712-05, 36612-01
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Disitribution - USA Nationwide in the states of Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming and the countries of Quezon City, Philippines, Singapore, and Panama City, Panama.
  • Descripción del producto
    TX1 Tissue Removal System disposable handpieces. || Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
  • Manufacturer
    American Optisurgical Inc
  • 1 Event
    • Retiro De Equipo (Recall) de TX1 Tissue Removal System
TX1 Tissue Removal System
  • Modelo / Serial
    Lot Numbers:  00614-03, 06513-02, 24913-01, 00713-06, 06514-02, 25313-01, 00814-02, 06914-01, 25513-02, 01114-02, 07213-04, 25613-01, 01514-03, 07713-18, 26113-06, 01714-04, 08113-04, 26313-04, 01813-02, 08413-13, 26713-04, 02314-08, 09313-05, 26813-01, 02413-04, 10213-07, 27013-10, 02714-02, 10613-01, 27613-02, 02914-01, 11213-07, 28013-05, 03014-02, 11613-06, 28313-02, 03113-02, 12113-02, 29513-03, 03114-02, 12713-03, 29713-01, 03414-03, 13413-01, 30913-07, 03514-05, 14413-05, 31113-08, 03714-03, 15013-04, 31513-02, 03814-06, 15413-02, 31713-05, 04114-02, 15413-03, 32213-01, 04213-01, 16513-04, 32413-01, 04214-05, 17013-02, 32613-01, 04414-03, 17013-09, 32913-07, 04514-02, 17613-08, 33613-09, 04814-07, 17913-16, 33813-05, 05014-02, 18413-05, 34013-03, 05113-01, 18413-06, 34313-01, 05113-02, 18613-03, 34413-04, 05114-09, 19213-03, 34513-04, 05514-01, 19713-04, 34713-08, 05614-04, 20713-06, 35113-01, 05713-03, 21813-01, 35213-03, 05714-10, 23913-01, 36013-01, 06313-05, 24113-04, 36113-02, 06314-04, 24213-04, and 36413-05.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.
  • Descripción del producto
    TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
  • Manufacturer
    Tenex Health Inc
  • 1 Event
    • Retiro De Equipo (Recall) de TX1 Tissue Removal System
JBAIDS Instrument System Software version 3.5.0.72.
  • Modelo / Serial
    Model Number(s): JRPD-SFW-0001
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Distributed USA (nationwide) and Guam.
  • Descripción del producto
    JBAIDS Instrument System Software version 3.5.0.72. || The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument provides an integrated environment for performing the required functions to control JBAIDS instruments and to perform PCR tests and analysis.
  • Manufacturer
    Biofire Defense
  • 1 Event
    • Retiro De Equipo (Recall) de JBAIDS Instrument System Software version 3.5.0.72.
DualCap Solo
  • Modelo / Serial
    Lot 1406509
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: CT, GA, MD, and PA. .
  • Descripción del producto
    DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. || When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
  • Manufacturer
    Catheter Connections, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de DualCap Solo
Amerigel Hydrogel Wound Dressing
  • Modelo / Serial
    Model # A2001, Lot #s: YWD13, YWD15, YWD16, 2WD01, 2WD02, 2WD03, 2WD04, 2WD05, 2WD08, 2WD09, 2WD11, 2WD13, 2WD14, 2WD15, 2WD17, 2WD18, 3WD01, 3WD02, 3WD03, 3WD04, 3WD05
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
  • Descripción del producto
    Amerigel Hydrogel Wound Dressing || Wound management
  • Manufacturer
    Amerx Health Care Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Amerigel Hydrogel Wound Dressing
Amerigel Postop Surgical Kits
  • Modelo / Serial
    Model # A2002, Lot #s: JCA0086, JCA0087, JCA0088, JCA0089, JCA0090, JCA0091, JCA0092, JCA0093, JCA0094, JCA0095, JCA0096, JCA0097, JCA0098, JCA0099, JCA0100, JCA0101, JCA0102, JCA0103, JCA0104, JCA0105, JCA0106
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
  • Descripción del producto
    Amerigel Post-op Surgical Kits || Wound management
  • Manufacturer
    Amerx Health Care Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Amerigel Postop Surgical Kits
Amerigel Daily Dressing Packets
  • Modelo / Serial
    Model # A2003, Lot #s: 2WD07
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
  • Descripción del producto
    Amerigel Daily Dressing Packets || Wound management
  • Manufacturer
    Amerx Health Care Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Amerigel Daily Dressing Packets
Amerigel Saturated Gauze Dressing
  • Modelo / Serial
    Model # A5002, Lot #s: 05368, 05345, 09282, 10295, 12201, 12303, 12322, 12328, 13100, 13115, 13180
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
  • Descripción del producto
    Amerigel Saturated Gauze Dressing || Wound management
  • Manufacturer
    Amerx Health Care Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Amerigel Saturated Gauze Dressing
Integra
  • Modelo / Serial
    Lot Numbers: 130849;1132912;1132913;1132914;1133101;1133102;1133103;1133104;1133105;1133495;1134005;1134006;1134007;1134120;1134121;1134122;1134124;1134126;1134128;1134130;1134131;1134132;1134133;1134620;1134621;1134669;1134670;1134671;1134671;1134694;1134695;1140357;1141561;1141562;1141645;1141754;1141563;1141564;1141647;1142352;1142353;1142409; & 1142410
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Australia, Bulgaria, Canada, Germany, Great Britain, Greece, Hungary, Indonesia, Israel, Italy, Japan, Mexico, Portugal, Spain, Sweden, Thailand, Turkey, and Wales.
  • Descripción del producto
    Integra Selector Kit || Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing lumen transmits aspirated fluid and tissue back to the system console. The aspirator is intended to be used to facilitate the removal of cellular and other unwanted soft tissue. The system provides selective tissue disintegration with simultaneous irrigation and aspiration. The system has been designed for use by surgeons in the areas of neurosurgery and gastroenterology including laparoscopic procedures. Its use in other procedures is regarded as experimental and is thus subjecto to appropriate local regulatory approval
  • Manufacturer
    Integra LifeSciences Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Integra
HARMONIC ACE 7 Laparoscopic Shears
  • Modelo / Serial
    Model # HARH23: Batch # L90K2V, Exp Date 2019-02; Batch # L90K2W, Exp Date 2019-02; Batch # L90K2X, Exp Date 2019-02; Batch # L90V6P, Exp Date 2019-03; Batch #, L9109W, Exp Date, 2019-03; Batch #, L91739, Exp Date, 2019-04; Batch #, L91F3X, Exp Date, 2019-05; Batch #, L91H6F, Exp Date, 2019-05; Batch #, L91M6D, Exp Date, 2019-06; Batch #, L91W4Z, Exp Date, 2019-06; Batch #, L91Z2W, Exp Date, 2019-07; Batch #, L92002, Exp Date, 2019-07; Batch #, L9214D, Exp Date, 2019-07; Batch #, L92194, Exp Date, 2019-07; Batch #, L92673, Exp Date, 2019-08; Batch #, L92E3H, Exp Date, 2019-08; Batch #, L92G7W, Exp Date, 2019-09; Batch #, L92L5R, Exp Date, 2019-09; Batch #, L92L8T, Exp Date, 2019-09; Batch #, L92R3H, Exp Date, 2019-09; Batch #, L92U7M, Exp Date, 2019-10; Batch #, L92W9M, Exp Date, 2019-10; Batch #, L92Y2K, Exp Date, 2019-10; Batch #, L92Y5M, Exp Date, 2019-10; Batch #, L92Z3M, Exp Date, 2019-10; Batch #, L9361Y, Exp Date, 2019-11; Batch #, M9013T, Exp Date, 2019-12; Batch #, M90214, Exp Date, 2019-12; Batch #, M9029F, Exp Date, 2019-12; Batch #, M9041P, Exp Date, 2019-12; Batch #, M90550, Exp Date, 2019-12; Batch #, M90681, Exp Date, 2019-12; Batch #, M9094Y, Exp Date, 2019-12; Batch #, M90H4Y, Exp Date, 2020-01; Batch #, M90K10, Exp Date, 2020-01; Batch #, M90L6V, Exp Date, 2020-02; Batch #, M90N41, Exp Date, 2020-02; Batch #, M90U2V, Exp Date, 2020-02; Batch #, M90X1T, Exp Date, 2020-02; Batch #, M90Y5Y, Exp Date, 2020-02; Batch #, M9107H, Exp Date, 2020-03; Batch #, M9134X, Exp Date, 2020-03; Batch #, M9159T, Exp Date, 2020-03; Batch #, M91788, Exp Date, 2020-03; Batch #, M9180C, Exp Date, 2020-03; Batch #, M91D2P, Exp Date, 2020-04; Batch #, M91D7P, Exp Date, 2020-04; Batch #, M91E14, Exp Date, 2020-04; Batch #, M91J5X, Exp Date, 2020-04; Batch #, M91L28, Exp Date, 2020-05; Batch #, M91M8D, Exp Date, 2020-05; Batch #, M91P44, Exp Date, 2020-05; Batch #, M91P5A, Exp Date, 2020-05; Batch #, M91T75, Exp Date, 2020-05; Batch #, M91W2T, Exp Date, 2020-05; Batch #, M91W5C, Exp Date, 2020-05; Batch #, M91X4J, Exp Date, 2020-05; Batch #, M91X9A, Exp Date, 2020-06; Batch #, M91X9U, Exp Date, 2020-06; Batch #, M92303, Exp Date, 2020-06; Batch #, M9232T, Exp Date, 2020-06; Batch #, M9237E, Exp Date, 2020-06; Batch #, M9243M, Exp Date, 2020-06; Batch #, M9244V, Exp Date, 2020-06; Batch #, M92795, Exp Date, 2020-07; Batch #, M9283L, Exp Date, 2020-07; Batch #, M9294A, Exp Date, 2020-07; Batch #, M92961, Exp Date, 2020-07; Batch #, M92C66, Exp Date, 2020-07; Batch #, M92C90, Exp Date, 2020-07; Batch #, M92E9X, Exp Date, 2020-07; Batch #, M92G56, Exp Date, 2020-07; Batch #, M92G79, Exp Date, 2020-07; Batch #, M92J3C, Exp Date, 2020-08; Batch #, M92L92, Exp Date, 2020-08 & Batch #, M92N00, Exp Date, 2020-08.  Model # HARH36: Batch #, L90K4P, Exp Date, 2019-02; Batch #, L90W33, Exp Date, 2019-03; Batch #, L90W7K, Exp Date, 2019-03; Batch #, L91023, Exp Date, 2019-03; Batch #, L9103T, Exp Date, 2019-03; Batch #, L91080, Exp Date, 2019-03; Batch #, L9110Z, Exp Date, 2019-03; Batch #, L91144, Exp Date, 2019-03; Batch #, L9124Z, Exp Date, 2019-04; Batch #, L9128A, Exp Date, 2019-04; Batch #, L9131N, Exp Date, 2019-04; Batch #, L9138J, Exp Date, 2019-04; Batch #, L9142T, Exp Date, 2019-04; Batch #, L91467, Exp Date, 2019-04; Batch #, L9150V, Exp Date, 2019-04; Batch #, L91562, Exp Date, 2019-04; Batch #, L91884, Exp Date, 2019-04; Batch #, L9191F, Exp Date, 2019-04; Batch #, L91D1W, Exp Date, 2019-05; Batch #, L91D3V, Exp Date, 2019-05; Batch #, L91E0Y, Exp Date, 2019-05; Batch #, L91E5M, Exp Date, 2019-05; Batch #, L91E8N, Exp Date, 2019-05; Batch #, L91H0G, Exp Date, 2019-05; Batch #, L91H9R, Exp Date, 2019-05; Batch #, L91J2N, Exp Date, 2019-05; Batch #, L91K6G, Exp Date, 2019-05; Batch #, L91L6M, Exp Date, 2019-05; Batch #, L91P2Z, Exp Date, 2019-06; Batch #, L91P5D, Exp Date, 2019-06; Batch #, L91P99, Exp Date, 2019-06; Batch #, L91T2H, Exp Date, 2019-06; Batch #, L91T7E, Exp Date, 2019-06; Batch #, L91T9U, Exp Date, 2019-06; Batch #, L91V2X, Exp Date, 2019-06; Batch #, L91V62, Exp Date, 2019-06; Batch #, L91W1T, Exp Date, 2019-06; Batch #, L91X5P, Exp Date, 2019-07; Batch #, L91Y0X, Exp Date, 2019-07; Batch #, L91Y8W, Exp Date, 2019-07; Batch #, L91Z0N, Exp Date, 2019-07; Batch #, L9204R, Exp Date, 2019-07; Batch #, L92092, Exp Date, 2019-07; Batch #, L9225Y, Exp Date, 2019-07; Batch #, L9232V, Exp Date, 2019-07; Batch #, L9238R, Exp Date, 2019-07; Batch #, L9244H, Exp Date, 2019-07; Batch #, L92524, Exp Date, 2019-07; Batch #, L9255U, Exp Date, 2019-08; Batch #, L9259G, Exp Date, 2019-08; Batch #, L9272N, Exp Date, 2019-08; Batch #, L9284X, Exp Date, 2019-08; Batch #, L9285V, Exp Date, 2019-08; Batch #, L9290A, Exp Date, 2019-08; Batch #, L92921, Exp Date, 2019-08; Batch #, L92952, Exp Date, 2019-08; Batch #, L92987, Exp Date, 2019-08; Batch #, L92A89, Exp Date, 2019-08; Batch #, L92C3L, Exp Date, 2019-08; Batch #, L92C57, Exp Date, 2019-08; Batch #, L92D3K, Exp Date, 2019-08; Batch #, L92D4D, Exp Date, 2019-08; Batch #, L92D9H, Exp Date, 2019-08; Batch #, L92E43, Exp Date, 2019-08; Batch #, L92E8A, Exp Date, 2019-08; Batch #, L92F0U, Exp Date, 2019-08; Batch #, L92F2W, Exp Date, 2019-08; Batch #, L92F5A, Exp Date, 2019-09; Batch #, L92G2F, Exp Date, 2019-09; Batch #, L92G4R, Exp Date, 2019-09; Batch #, L92G9M, Exp Date, 2019-09; Batch #, L92J1A, Exp Date, 2019-09; Batch #, L92J1K, Exp Date, 2019-09; Batch #, L92K1F, Exp Date, 2019-09; Batch #, L92K66, Exp Date, 2019-09; Batch #, L92K9X, Exp Date, 2019-09; Batch #, L92P2A, Exp Date, 2019-09; Batch #, L92P4K, Exp Date, 2019-09; Batch #, L92P5A, Exp Date, 2019-09; Batch #, L92R16, Exp Date, 2019-09; Batch #, L92R2M, Exp Date, 2019-09; Batch #, L92R79, Exp Date, 2019-09; Batch #, L92R95, Exp Date, 2019-09; Batch #, L92T2A, Exp Date, 2019-10; Batch #, L92T64, Exp Date, 2019-10; Batch #, L92T6X, Exp Date, 2019-10; Batch #, L92U09, Exp Date, 2019-10; Batch #, L92U51, Exp Date, 2019-10; Batch #, L92U5K, Exp Date, 2019-10; Batch #, L92V39, Exp Date, 2019-10; Batch #, L92V4E, Exp Date, 2019-10; Batch #, L92V89, Exp Date, 2019-10; Batch #, L92W83, Exp Date, 2019-10; Batch #, L92X1Z, Exp Date, 2019-10; Batch #, L92X5D, Exp Date, 2019-10; Batch #, L92X73, Exp Date, 2019-10; Batch #, L92Y5D, Exp Date, 2019-10; Batch #, L92Y9L, Exp Date, 2019-10; Batch #, L92Z0W, Exp Date, 2019-10; Batch #, L92Z1R, Exp Date, 2019-10; Batch #, L92Z7H, Exp Date, 2019-10; Batch #, L9302N, Exp Date, 2019-10; Batch #, L9307C, Exp Date, 2019-10; Batch #, L93086, Exp Date, 2019-10; Batch #, L9311H, Exp Date, 2019-10; Batch #, L93122, Exp Date, 2019-10; Batch #, L93196, Exp Date, 2019-11; Batch #, L93200, Exp Date, 2019-11; Batch #, L9325A, Exp Date, 2019-11; Batch #, L9327J, Exp Date, 2019-11; Batch #, L93280, Exp Date, 2019-11; Batch #, L9330R, Exp Date, 2019-11; Batch #, L9330W, Exp Date, 2019-11; Batch #, L9333C, Exp Date, 2019-11; Batch #, L9334R, Exp Date, 2019-11; Batch #, L9338D, Exp Date, 2019-11; Batch #, L9339Z, Exp Date, 2019-11; Batch #, L9343C, Exp Date, 2019-11; Batch #, L9347A, Exp Date, 2019-11; Batch #, L9348U, Exp Date, 2019-11; Batch #, L9352A, Exp Date, 2019-11; Batch #, L9353X, Exp Date, 2019-11; Batch #, L9353Y, Exp Date, 2019-11; Batch #, L9356M, Exp Date, 2019-11; Batch #, L9361E, Exp Date, 2019-11; Batch #, L9362R, Exp Date, 2019-11; Batch #, L9362Z, Exp Date, 2019-11; Batch #, L9364G, Exp Date, 2019-11; Batch #, M9002F, Exp Date, 2019-12; Batch #, M9004D, Exp Date, 2019-12; Batch #, M9004N, Exp Date, 2019-12; Batch #, M9016Y, Exp Date, 2019-12; Batch #, M9017T, Exp Date, 2019-12; Batch #, M90235, Exp Date, 2019-12; Batch #, M90275, Exp Date, 2019-12; Batch #, M9027Z, Exp Date, 2019-12; Batch #, M9030P, Exp Date, 2019-12; Batch #, M9038T, Exp Date, 2019-12; Batch #, M90444, Exp Date, 2019-12; Batch #, M9046H, Exp Date, 2019-12; Batch #, M90494, Exp Date, 2019-12; Batch #, M9051C, Exp Date, 2019-12; Batch #, M9057H, Exp Date, 2019-12; Batch #, M90601, Exp Date, 2019-12; Batch #, M9064E, Exp Date, 2019-12; Batch #, M9069Y, Exp Date, 2019-12; Batch #, M9071X, Exp Date, 2019-12; Batch #, M90764, Exp Date, 2019-12; Batch #, M9083G, Exp Date, 2019-12; Batch #, M90880, Exp Date, 2019-12; Batch #, M90902, Exp Date, 2019-12; Batch #, M9091P, Exp Date, 2019-12; Batch #, M9097G, Exp Date, 2019-12; Batch #, M90A5M, Exp Date, 2020-01; Batch #, M90A8A, Exp Date, 2020-01; Batch #, M90C39, Exp Date, 2020-01; Batch #, M90C87, Exp Date, 2020-01; Batch #, M90C88, Exp Date, 2020-01; Batch #, M90C89, Exp Date, 2020-01; Batch #, M90D1E, Exp Date, 2020-01; Batch #, M90D8J, Exp Date, 2020-01; Batch #, M90D9T, Exp Date, 2020-01; Batch #, M90E1U, Exp Date, 2020-01; Batch #, M90F06, Exp Date, 2020-01; Batch #, M90F1W, Exp Date, 2020-01; Batch #, M90F3K, Exp Date, 2020-01; Batch #, M90F5Y, Exp Date, 2020-01; Batch #, M90G00, Exp Date, 2020-01; Batch #, M90G2Y, Exp Date, 2020-01; Batch #, M90G78, Exp Date, 2020-01; Batch #, M90G7Y, Exp Date, 2020-01; Batch #, M90H28, Exp Date, 2020-01; Batch #, M90H7D, Exp Date, 2020-01; Batch #, M90H7E, Exp Date, 2020-01; Batch #, M90H84, Exp Date, 2020-01; Batch #, M90J09, Exp Date, 2020-01; Batch #, M90J6R, Exp Date, 2020-01; Batch #, M90J7R, Exp Date, 2020-01; Batch #, M90K0A, Exp Date, 2020-01; Batch #, M90K5F, Exp Date, 2020-01; Batch #, M90K7A, Exp Date, 2020-01; Batch #, M90K8X, Exp Date, 2020-01; Batch #, M90L1F, Exp Date, 2020-02; Batch #, M90L2K, Exp Date, 2020-02; Batch #, M90L3Z, Exp Date, 2020-02; Batch #, M90L6U, Exp Date, 2020-02; Batch #, M90M34, Exp Date, 2020-02; Batch #, M90M52, Exp Date, 2020-02; Batch #, M90N1M, Exp Date, 2020-02; Batch #, M90N4Z, Exp Date, 2020-02; Batch #, M90N7V, Exp Date, 2020-02  , Batch #, M90P2U, Exp Date, 2020-02; Batch #, M90P5J, Exp Date, 2020-02; Batch #, M90P7K, Exp Date, 2020-02; Batch #, M90R0A, Exp Date, 2020-02; Batch #, M90R2M, Exp Date, 2020-02; Batch #, M90R2N, Exp Date, 2020-02; Batch #, M90R4W, Exp Date, 2020-02; Batch #, M90R7W, Exp Date, 2020-02; Batch #, M90T1J, Exp Date, 2020-02; Batch #, M90T73, Exp Date, 2020-02; Batch #, M90T98, Exp Date, 2020-02; Batch #, M90U35, Exp Date, 2020-02; Batch #, M90U7F, Exp Date, 2020-02; Batch #, M90V0Y, Exp Date, 2020-02; Batch #, M90V32, Exp Date, 2020-02; Batch #, M90V5R, Exp Date, 2020-02; Batch #, M90V91, Exp Date, 2020-02; Batch #, M90W3V, Exp Date, 2020-02; Batch #, M90W6F, Exp Date, 2020-02; Batch #, M90W9J, Exp Date, 2020-02; Batch #, M90X29, Exp Date, 2020-02; Batch #, M90X4P, Exp Date, 2020-02; Batch #, M90X7D, Exp Date, 2020-02; Batch #, M90Y2N, Exp Date, 2020-02; Batch #, M90Y3U, Exp Date, 2020-02; Batch #, M90Y6R, Exp Date, 2020-02; Batch #, M90Y7Z, Exp Date, 2020-03; Batch #, M90Y9P, Exp Date, 2020-03; Batch #, M90Z7K, Exp Date, 2020-03; Batch #, M9100N, Exp Date, 2020-03; Batch #, M9101R, Exp Date, 2020-03; Batch #, M9103R, Exp Date, 2020-03; Batch #, M91110, Exp Date, 2020-03; Batch #, M9111J, Exp Date, 2020-03; Batch #, M9113E, Exp Date, 2020-03; Batch #, M9115C, Exp Date, 2020-03; Batch #, M9117X, Exp Date, 2020-03; Batch #, M91206, Exp Date, 2020-03; Batch #, M9122P, Exp Date, 2020-03; Batch #, M9124V, Exp Date, 2020-03; Batch #, M9127U, Exp Date, 2020-03; Batch #, M9129X, Exp Date, 2020-03; Batch #, M9132N, Exp Date, 2020-03; Batch #, M9134W, Exp Date, 2020-03; Batch #, M91398, Exp Date, 2020-03; Batch #, M9141W, Exp Date, 2020-03; Batch #, M9143P, Exp Date, 2020-03; Batch #, M9145E, Exp Date, 2020-03; Batch #, M9152A, Exp Date, 2020-03; Batch #, M9155F, Exp Date, 2020-03; Batch #, M9155G, Exp Date, 2020-03; Batch #, M9161E, Exp Date, 2020-03; Batch #, M9162M, Exp Date, 2020-03; Batch #, M9168V, Exp Date, 2020-03; Batch #, M91713, Exp Date, 2020-03; Batch #, M9172G, Exp Date, 2020-03; Batch #, M9176J, Exp Date, 2020-03; Batch #, M9180D, Exp Date, 2020-03; Batch #, M9180E, Exp Date, 2020-03; Batch #, M91848, Exp Date, 2020-04; Batch #, M91874, Exp Date, 2020-04; Batch #, M91897, Exp Date, 2020-04; Batch #, M91918, Exp Date, 2020-04; Batch #, M91950, Exp Date, 2020-04; Batch #, M91A06, Exp Date, 2020-04; Batch #, M91A3L, Exp Date, 2020-04; Batch #, M91C5U, Exp Date, 2020-04; Batch #, M91C8D, Exp Date, 2020-04; Batch #, M91D6Y, Exp Date, 2020-04; Batch #, M91D8F, Exp Date, 2020-04; Batch #, M91D8P, Exp Date, 2020-04; Batch #, M91E35, Exp Date, 2020-04; Batch #, M91E71, Exp Date, 2020-04; Batch #, M91E8E, Exp Date, 2020-04; Batch #, M91F2E, Exp Date, 2020-04; Batch #, M91F5D, Exp Date, 2020-04; Batch #, M91F88, Exp Date, 2020-04; Batch #, M91G2U, Exp Date, 2020-04; Batch #, M91G35, Exp Date, 2020-04; Batch #, M91G3Z, Exp Date, 2020-04; Batch #, M91G85, Exp Date, 2020-04; Batch #, M91H3F, Exp Date, 2020-04; Batch #, M91H6F, Exp Date, 2020-04; Batch #, M91H9G, Exp Date, 2020-04; Batch #, M91H9H, Exp Date, 2020-04; Batch #, M91J6A, Exp Date, 2020-04; Batch #, M91J7U, Exp Date, 2020-04; Batch #, M91J9U, Exp Date, 2020-04; Batch #, M91J9Y, Exp Date, 2020-04; Batch #, M91J9Z, Exp Date, 2020-04; Batch #, M91K5T, Exp Date, 2020-05; Batch #, M91L4L, Exp Date, 2020-05; Batch #, M91L4R, Exp Date, 2020-05; Batch #, M91L6V, Exp Date, 2020-05; Batch #, M91M03, Exp Date, 2020-05; Batch #, M91M06, Exp Date, 2020-05; Batch #, M91M1Y, Exp Date, 2020-05; Batch #, M91M29, Exp Date, 2020-05; Batch #, M91M35, Exp Date, 2020-05; Batch #, M91M5Z, Exp Date, 2020-05; Batch #, M91M7M, Exp Date, 2020-05; Batch #, M91N0N, Exp Date, 2020-05; Batch #, M91N15, Exp Date, 2020-05; Batch #, M91N2N, Exp Date, 2020-05; Batch #, M91N2P, Exp Date, 2020-05; Batch #, M91N2T, Exp Date, 2020-05; Batch #, M91N6Z, Exp Date, 2020-05; Batch #, M91N9G, Exp Date, 2020-05; Batch #, M91P2C, Exp Date, 2020-05; Batch #, M91P2D, Exp Date, 2020-05; Batch #, M91P8K, Exp Date, 2020-05; Batch #, M91P91, Exp Date, 2020-05; Batch #, M91R04, Exp Date, 2020-05; Batch #, M91R8A, Exp Date, 2020-05; Batch #, M91R8C, Exp Date, 2020-05; Batch #, M91R94, Exp Date, 2020-05; Batch #, M91T18, Exp Date, 2020-05; Batch #, M91T1N, Exp Date, 2020-05; Batch #, M91T2C, Exp Date, 2020-05; Batch #, M91T2M, Exp Date, 2020-05; Batch #, M91T41, Exp Date, 2020-05; Batch #, M91T7A, Exp Date, 2020-05; Batch #, M91T8F, Exp Date, 2020-05; Batch #, M91U2N, Exp Date, 2020-05; Batch #, M91U46, Exp Date, 2020-05; Batch #, M91U72, Exp Date, 2020-05; Batch #, M91U77, Exp Date, 2020-05; Batch #, M91U80, Exp Date, 2020-05; Batch #, M91U8C, Exp Date, 2020-05; Batch #, M91V2E, Exp Date, 2020-05; Batch #, M91V5J, Exp Date, 2020-05; Batch #, M91V72, Exp Date, 2020-05; Batch #, M91V7W, Exp Date, 2020-05; Batch #, M91V80, Exp Date, 2020-05; Batch #, M91W0E, Exp Date, 2020-05; Batch #, M91W38, Exp Date, 2020-05; Batch #, M91W5F, Exp Date, 2020-05; Batch #, M91W88, Exp Date, 2020-05; Batch #, M91W90, Exp Date, 2020-05; Batch #, M91X06, Exp Date, 2020-05; Batch #, M91X32, Exp Date, 2020-05; Batch #, M91X4F, Exp Date, 2020-05; Batch #, M91X4H, Exp Date, 2020-05; Batch #, M91X4K, Exp Date, 2020-05; Batch #, M91X6K, Exp Date, 2020-05; Batch #, M91X7Y, Exp Date, 2020-06; Batch #, M91Y2G, Exp Date, 2020-06; Batch #, M91Y3C, Exp Date, 2020-06; Batch #, M91Y71, Exp Date, 2020-06; Batch #, M91Y8T, Exp Date, 2020-06; Batch #, M91Z0X, Exp Date, 2020-06; Batch #, M91Z23, Exp Date, 2020-06; Batch #, M91Z39, Exp Date, 2020-06; Batch #, M91Z5E, Exp Date, 2020-06; Batch #, M91Z65, Exp Date, 2020-06; Batch #, M92015, Exp Date, 2020-06; Batch #, M9201W, Exp Date, 2020-06; Batch #, M9204A, Exp Date, 2020-06; Batch #, M9204C, Exp Date, 2020-06; Batch #, M9210M, Exp Date, 2020-06; Batch #, M92120, Exp Date, 2020-06; Batch #, M92141, Exp Date, 2020-06; Batch #, M9214Y, Exp Date, 2020-06; Batch #, M9215L, Exp Date, 2020-06; Batch #, M9217U, Exp Date, 2020-06; Batch #, M9219T, Exp Date, 2020-06; Batch #, M9221P, Exp Date, 2020-06; Batch #, M92233, Exp Date, 2020-06; Batch #, M9226X, Exp Date, 2020-06; Batch #, M9228L, Exp Date, 2020-06; Batch #, M9231D, Exp Date, 2020-06; Batch #, M9232M, Exp Date, 2020-06; Batch #, M92356, Exp Date, 2020-06; Batch #, M9237D, Exp Date, 2020-06; Batch #, M9239T, Exp Date, 2020-06; Batch #, M9240M, Exp Date, 2020-06; Batch #, M9241E, Exp Date, 2020-06; Batch #, M9243X, Exp Date, 2020-06; Batch #, M92443, Exp Date, 2020-06; Batch #, M9246N, Exp Date, 2020-06; Batch #, M9249D, Exp Date, 2020-06; Batch #, M92517, Exp Date, 2020-06; Batch #, M9251J, Exp Date, 2020-06; Batch #, M92554, Exp Date, 2020-06; Batch #, M9255P, Exp Date, 2020-06; Batch #, M9259G, Exp Date, 2020-06; Batch #, M9259T, Exp Date, 2020-06; Batch #, M92613, Exp Date, 2020-06; Batch #, M92634, Exp Date, 2020-06; Batch #, M9264E, Exp Date, 2020-06; Batch #, M9264N, Exp Date, 2020-06; Batch #, M92673, Exp Date, 2020-06; Batch #, M9269M, Exp Date, 2020-07; Batch #, M92718, Exp Date, 2020-07; Batch #, M92738, Exp Date, 2020-07; Batch #, M9275D, Exp Date, 2020-07; Batch #, M9275X, Exp Date, 2020-07; Batch #, M92783, Exp Date, 2020-07; Batch #, M9278N, Exp Date, 2020-07; Batch #, M9280J, Exp Date, 2020-07; Batch #, M92839, Exp Date, 2020-07; Batch #, M9284P, Exp Date, 2020-07; Batch #, M92880, Exp Date, 2020-02; Batch #, M92894, Exp Date, 2020-07; Batch #, M92928, Exp Date, 2020-07; Batch #, M92935, Exp Date, 2020-07; Batch #, M9295Y, Exp Date, 2020-07; Batch #, M9295Z, Exp Date, 2020-07; Batch #, M92A3A, Exp Date, 2020-07; Batch #, M92A59, Exp Date, 2020-07; Batch #, M92A84, Exp Date, 2020-07; Batch #, M92A8U, Exp Date, 2020-07; Batch #, M92C0A, Exp Date, 2020-07; Batch #, M92C2U, Exp Date, 2020-07; Batch #, M92C51, Exp Date, 2020-07; Batch #, M92C76, Exp Date, 2020-07; Batch #, M92C8Z, Exp Date, 2020-07; Batch #, M92C9H, Exp Date, 2020-07; Batch #, M92D1U, Exp Date, 2020-07; Batch #, M92D2G, Exp Date, 2020-07; Batch #, M92D6K, Exp Date, 2020-07; Batch #, M92D6N, Exp Date, 2020-07; Batch #, M92D6P, Exp Date, 2020-07; Batch #, M92D6R, Exp Date, 2020-07; Batch #, M92E1F, Exp Date, 2020-07; Batch #, M92E36, Exp Date, 2020-07; Batch #, M92E4N, Exp Date, 2020-07; Batch #, M92E5X, Exp Date, 2020-07; Batch #, M92E6U, Exp Date, 2020-07; Batch #, M92E7R, Exp Date, 2020-07; Batch #, M92E9V, Exp Date, 2020-07; Batch #, M92F1U, Exp Date, 2020-07; Batch #, M92F1V, Exp Date, 2020-07; Batch #, M92F38, Exp Date, 2020-07; Batch #, M92F3A, Exp Date, 2020-07; Batch #, M92F5J, Exp Date, 2020-07; Batch #, M92F7C, Exp Date, 2020-07; Batch #, M92G0M, Exp Date, 2020-07; Batch #, M92G1P, Exp Date, 2020-07; Batch #, M92G41, Exp Date, 2020-07; Batch #, M92G5F, Exp Date, 2020-07; Batch #, M92G7C, Exp Date, 2020-07; Batch #, M92H07, Exp Date, 2020-07; Batch #, M92H13, Exp Date, 2020-07; Batch #, M92H24, Exp Date, 2020-07; Batch #, M92H3H, Exp Date, 2020-07; Batch #, M92H4M, Exp Date, 2020-07; Batch #, M92H7D, Exp Date, 2020-07; Batch #, M92H9Z, Exp Date, 2020-07; Batch #, M92J2Y, Exp Date, 2020-07; Batch #, M92J9Z, Exp Date, 2020-08; Batch #, M92K27, Exp Date, 2020-08; Batch #, M92K36, Exp Date, 2020-08; Batch #, M92K53, Exp Date, 2020-08; Batch #, M92K71, Exp Date, 2020-08; Batch #, M92K7F, Exp Date, 2020-08; Batch #, M92L14, Exp Date, 2020-08; Batch #, M92L1L, Exp Date, 2020-08; Batch #, M92L1V, Exp Date, 2020-08; Batch #, M92M3V, Exp Date, 2020-08; Batch #, M92M76, Exp Date, 2020-08; Batch #, M92M9G, Exp Date, 2020-08; Batch #, M92N2A, Exp Date, 2020-08; Batch #, M92N4Y, Exp Date, 2020-08 & Batch #, M92N72, Exp Date, 2020-08.  Model # HARH45: Batch #, L90K4R, Exp Date, 2019-02; Batch #, L90V8F, Exp Date, 2019-03; Batch #, L90X10, Exp Date, 2019-03; Batch #, L91358, Exp Date, 2019-04; Batch #, L91600, Exp Date, 2019-04; Batch #, L9166U, Exp Date, 2019-04; Batch #, L9168T, Exp Date, 2019-04; Batch #, L91809, Exp Date, 2019-04; Batch #, L91E83, Exp Date, 2019-05; Batch #, L91G7W, Exp Date, 2019-05; Batch #, L91J6R, Exp Date, 2019-05; Batch #, L91M0D, Exp Date, 2019-06; Batch #, L91M6C, Exp Date, 2019-06; Batch #, L91R4J, Exp Date, 2019-06; Batch #, L91U69, Exp Date, 2019-06; Batch #, L91W66, Exp Date, 2019-06; Batch #, L91Y4Y, Exp Date, 2019-07; Batch #, L91Z72, Exp Date, 2019-07; Batch #, L9207J, Exp Date, 2019-07; Batch #, L92360, Exp Date, 2019-07; Batch #, L9236W, Exp Date, 2019-07; Batch #, L9246M, Exp Date, 2019-07; Batch #, L9252P, Exp Date, 2019-07; Batch #, L9257K, Exp Date, 2019-08; Batch #, L92619, Exp Date, 2019-08; Batch #, L92690, Exp Date, 2019-08; Batch #, L9281C, Exp Date, 2019-08; Batch #, L9288P, Exp Date, 2019-08; Batch #, L9294J, Exp Date, 2019-08; Batch #, L92A2U, Exp Date, 2019-08; Batch #, L92A8A, Exp Date, 2019-08; Batch #, L92C8U, Exp Date, 2019-08; Batch #, L92D7A, Exp Date, 2019-08; Batch #, L92H1J, Exp Date, 2019-09; Batch #, L92H3T, Exp Date, 2019-09; Batch #, L92H79, Exp Date, 2019-09; Batch #, L92H7K, Exp Date, 2019-09; Batch #, L92J40, Exp Date, 2019-09; Batch #, L92K54, Exp Date, 2019-09; Batch #, L92K8Z, Exp Date, 2019-09; Batch #, L92L1C, Exp Date, 2019-09; Batch #, L92M3W, Exp Date, 2019-09; Batch #, L92P9N, Exp Date, 2019-09; Batch #, L92T19, Exp Date, 2019-10; Batch #, L92U1H, Exp Date, 2019-10; Batch #, L92V3L, Exp Date, 2019-10; Batch #, L92V8R, Exp Date, 2019-10; Batch #, L92W46, Exp Date, 2019-10; Batch #, L92X6G, Exp Date, 2019-10; Batch #, L92Y3C, Exp Date, 2019-10; Batch #, L92Y8Z, Exp Date, 2019-10; Batch #, L92Z8P, Exp Date, 2019-10; Batch #, L9303M, Exp Date, 2019-10; Batch #, L93240, Exp Date, 2019-11; Batch #, L93248, Exp Date, 2019-11; Batch #, L93426, Exp Date, 2019-11; Batch #, L9359C, Exp Date, 2019-11; Batch #, M9007E, Exp Date, 2019-12; Batch #, M9007F, Exp Date, 2019-12; Batch #, M90138, Exp Date, 2019-12; Batch #, M9024R, Exp Date, 2019-12; Batch #, M9025P, Exp Date, 2019-12; Batch #, M9030N, Exp Date, 2019-12; Batch #, M9047L, Exp Date, 2019-12; Batch #, M90545, Exp Date, 2019-12; Batch #, M9062G, Exp Date, 2019-12; Batch #, M9080T, Exp Date, 2019-12; Batch #, M90858, Exp Date, 2019-12; Batch #, M9097F, Exp Date, 2019-12; Batch #, M90C11, Exp Date, 2020-01; Batch #, M90C5Y, Exp Date, 2020-01; Batch #, M90D61, Exp Date, 2020-01; Batch #, M90E1V, Exp Date, 2020-01; Batch #, M90F7R, Exp Date, 2020-01; Batch #, M90G3W, Exp Date, 2020-01; Batch #, M90H03, Exp Date, 2020-01; Batch #, M90J4R, Exp Date, 2020-01; Batch #, M90M71, Exp Date, 2020-02; Batch #, M90M9E, Exp Date, 2020-02; Batch #, M90P0E, Exp Date, 2020-02; Batch #, M90T4D, Exp Date, 2020-02; Batch #, M90U8F, Exp Date, 2020-02; Batch #, M90W1V, Exp Date, 2020-02; Batch #, M90X96, Exp Date, 2020-02; Batch #, M90Z1G, Exp Date, 2020-03; Batch #, M90Z52, Exp Date, 2020-03; Batch #, M91053, Exp Date, 2020-03; Batch #, M9125X, Exp Date, 2020-03; Batch #, M9141X, Exp Date, 2020-03; Batch #, M9145F, Exp Date, 2020-03; Batch #, M9164C, Exp Date, 2020-03; Batch #, M9166Y, Exp Date, 2020-03; Batch #, M91984, Exp Date, 2020-04; Batch #, M91D17, Exp Date, 2020-04; Batch #, M91F19, Exp Date, 2020-04; Batch #, M91G1N, Exp Date, 2020-04; Batch #, M91H11, Exp Date, 2020-04; Batch #, M91J0M, Exp Date, 2020-04; Batch #, M91J2G, Exp Date, 2020-04; Batch #, M91L0A, Exp Date, 2020-05; Batch #, M91M1C, Exp Date, 2020-05; Batch #, M91P13, Exp Date, 2020-05; Batch #, M91R3J, Exp Date, 2020-05; Batch #, M91R4M, Exp Date, 2020-05; Batch #, M91R53, Exp Date, 2020-05; Batch #, M91U3L, Exp Date, 2020-05; Batch #, M91V21, Exp Date, 2020-05; Batch #, M91X28, Exp Date, 2020-05; Batch #, M91X4G, Exp Date, 2020-05; Batch #, M91X6W, Exp Date, 2020-06; Batch #, M91Y1Y, Exp Date, 2020-06; Batch #, M91Y3D, Exp Date, 2020-06; Batch #, M91Y7J, Exp Date, 2020-06; Batch #, M9202G, Exp Date, 2020-06; Batch #, M92126, Exp Date, 2020-06; Batch #, M92189, Exp Date, 2020-06; Batch #, M9222C, Exp Date, 2020-06; Batch #, M9224U, Exp Date, 2020-06; Batch #, M9246P, Exp Date, 2020-06; Batch #, M9255N, Exp Date, 2020-06; Batch #, M9273G, Exp Date, 2020-07; Batch #, M92884, Exp Date, 2020-07; Batch #, M9291P, Exp Date, 2020-07; Batch #, M92A24, Exp Date, 2020-07; Batch #, M92A67, Exp Date, 2020-07; Batch #, M92D6L, Exp Date, 2020-07; Batch #, M92E0X, Exp Date, 2020-07; Batch #, M92F1X, Exp Date, 2020-07; Batch #, M92F5K, Exp Date, 2020-07; Batch #, M92F8N, Exp Date, 2020-07; Batch #, M92J31, Exp Date, 2020-08; Batch #, M92J9N, Exp Date, 2020-08; Batch #, M92K6E, Exp Date, 2020-08; Batch #, M92L5C, Exp Date, 2020-08; Batch #, M92L5T, Exp Date, 2020-08; Batch #, M92L7G, Exp Date, 2020-08 & Batch #, M92N47, Exp Date, 2020-08.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Distributed US (nationwide) including the District of Columbia & Puerto Rico and in the countries of ARUBA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, ECUADOR, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, MEXICO, PANAMA, PERU, PHILIPPINES, SINGAPORE, SINGAPORE, THAILAND, TAIWAN & VIETNAM.
  • Descripción del producto
    HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
  • Manufacturer
    Ethicon Endo-Surgery Inc
  • 1 Event
    • Retiro De Equipo (Recall) de HARMONIC ACE 7 Laparoscopic Shears
EVARREST
  • Modelo / Serial
    Product Code #EVT5024, Lot #U01F012A
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. || Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical.
  • Manufacturer
    Ethicon, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de EVARREST
Draco Enzymatic DeepCleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z
  • Modelo / Serial
    Lot Number: EXP20180616 and EXP20180622
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Distributed in the US.
  • Descripción del producto
    Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent || Catalogue Number: HY0305Z
  • Manufacturer
    Madison Polymeric Engineering
  • 1 Event
    • Retiro De Equipo (Recall) de Draco Enzymatic DeepCleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z
Footswitch accessory
  • Modelo / Serial
    Lot #1885744; Lot #1923802; Lot #1985221; Lot #2057996; Lot #2109587; Lot #2118507
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in 33 states: AL, AR, CA, CO, CT, FL, GA, IA, ID, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NM, NY, OH, OK, OR, PA, TN, TX, VA, WA, WI in the countries of Greece, South Africa, France, Germany, Italy, United Kingdom, Sweden, Netherlands, and Dominican Republic.
  • Descripción del producto
    Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 || Product Usage: || The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses are cleared for use in the US only: Gastrointestinal and Affiliated Organ Surgery including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery including removal of benign or malignant tumors or other unwanted soft tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy.
  • Manufacturer
    Integra LifeSciences Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Footswitch accessory
Nanosil Spray Gel
  • Modelo / Serial
    Product does not bear lot codes. All product lacking lot codes and expiration dates is being recalled.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : AL, MS, and MA.
  • Descripción del producto
    Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 || The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by microbial infections.
  • Manufacturer
    Conseal International, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Nanosil Spray Gel
Ultrasonic Surgical Aspirator
  • Modelo / Serial
    Serial numbers between 0100 and 1219 (inclusive)
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    1 distributor in Tucson, AZ, for further distribution to end users (physicians and medical facilities) nationwide & Puerto Rico, and in the following countries: Canada, Mexico, Australia, Switzerland, Israel, Saudi Arabia, Cyprus, Greece, Turkey, Germany, Dominican Republic, Sweden, Netherlands, China, Taiwan ROC, and S. Korea.
  • Descripción del producto
    LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling: MANUFACTURED BY: MISONIX, INC. EXCLUSIVELY FOR SALE BY MENTOR CORPORATION UNDER EXCLUSIVE LICENSE FROM SONIQUE SURGICAL, INC. MISONIX, INC. 1938 NEW HIGHWAY, FARMINGDALE, NY 11735. || Device was manufactured from September 1996 to present.
  • Manufacturer
    Misonix, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Ultrasonic Surgical Aspirator
MoiStir
  • Modelo / Serial
    Lots A2, 1193, 1209, 1233, 1260 and 1725.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, CONTENTS: 3 fibre-tipped swabsticks premoistened with MOI-STIR mouth moistening solutioon and saliva supplement; Product Nos. 55299-703-03 and 55299-703-25. Distributed by Kingswood Laboratories, Inc., Indianapolis, IN 46256-3316. Swabs are sold only in case quantities of 25 foil packs to the carton and 100 foil packs to the case.
  • Manufacturer
    Kingswood Laboratories,Inc
  • 1 Event
    • Retiro De Equipo (Recall) de MoiStir
Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hol...
  • Modelo / Serial
    Lot #6743 Item #s 7515ZA, 7515ZC, 7515ZD
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Vials were distributed to clinics, pharmacies and physicians nationwide.
  • Descripción del producto
    Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hollister-Stier Laboratories LLC Spokane, WA 99207 USA . Labels on case states 25 STERILE EMPTY VIALS 10 mL/20mm Closure CAUTION: For manufacturing, Processing or Repacking Rx only NON-RETURNABLE LOT Hollister-Stier Laboratories LLC Spokane, WA 99207
  • Manufacturer
    Hollister Stier Laboratories LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hollister-Stier Laboratories LLC Spokane, WA 99207 USA . Labels on case states 25 STERILE EMPTY VIALS 10 mL/20mm Closure CAUTION: For manufacturing, Processing or Repacking Rx only NON-RETURNABLE LOT Hollister-Stier Laboratories LLC Spokane, WA 99207
Mucotrol
  • Modelo / Serial
    Batch/Lot numbers 65AB, 97AB, and 99 AB
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.
  • Manufacturer
    Belcher Pharmaceuticals Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Mucotrol
Gebauer's Topical anesthetic skin refrigerant
  • Modelo / Serial
    Lot numbers 4256 expires 08-08; 4257 expires 10-08 and 4258 expires 12/08
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Gebauer''s Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only-103.5ml (3.5 fl. oz.) can. Product Number 0386-0008-02)
  • Manufacturer
    Gebauer Company
  • 1 Event
    • Retiro De Equipo (Recall) de Gebauer's Topical anesthetic skin refrigerant
Gebauer"s Topical anesthetic skin refrigerant
  • Modelo / Serial
    Lot Numbers: 8019 expires 08-08; 8020 expires 09-08; 8021 expires 10-08 and 8022 expires 12/08
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is intended for topical application to skin for use in controlling pain associated with injections and the temporary relief of minor sporsts injuries. Rx only- 3.5 fl. oz. (103.5ml) can-Product Number 0386-0004-04
  • Manufacturer
    Gebauer Company
  • 1 Event
    • Retiro De Equipo (Recall) de Gebauer"s Topical anesthetic skin refrigerant
Gebauer's Topical anesthetic skin refrigerant
  • Modelo / Serial
    Lot number 4009 expires 08-08; 4010 expires 12/08
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Gebauer''s Instant Ice Mist- is used like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries. 3.5 fl. oz. (103.5ml) can.-(Product Number: 0386-0010-05-)
  • Manufacturer
    Gebauer Company
  • 1 Event
    • Retiro De Equipo (Recall) de Gebauer's Topical anesthetic skin refrigerant
Gebauer"s Topical anesthetic skin refrigerant
  • Modelo / Serial
    Lot numbers 6015 expires 10-08 and 6016 expires 11/08
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Gebauer''s Instant Ice Medium Stream - temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries.-3.5 fl. oz. (103.5ml) can-(Product Number-0386-0010-01)
  • Manufacturer
    Gebauer Company
  • 1 Event
    • Retiro De Equipo (Recall) de Gebauer"s Topical anesthetic skin refrigerant
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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