Device Recall Integra

  • Modelo / Serial
    Container Lid, ¿ Size, Red; Container Lid, ¿ Size, Blue; Container Lid, ¿ Size, Red; Container Lid, ¿ Size, Gold; Container Lid, ¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US only to one repacker/relabeler and three medical facilities. The relabeler was identified as: KLS Martin, 11201 St. Johns Industrial Parkway S, Jacksonville, FL 32246 (904) 641-7746
  • Descripción del producto
    Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, || Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red || Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 || The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.
  • Manufacturer
  • 1 Event

Fabricante

85 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    H13L22013
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of FL, WI, AR, TN, TX, NC, MO, NM, NJ, CT, PA, NV, NY, CA, MI, WI, KS, and OH.
  • Descripción del producto
    Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. || Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use settings.
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: C10081, C10138, C10181, C10231, C10235, C11269, C11311, C12005, C12051, C12065, C12143, C12172, C12199, C12363, C13015, C13085, C13148, C13189, C13213, C13240, C13295, C13319, C13365, C14104, C14167
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) Distribution.
  • Descripción del producto
    INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO || Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
  • Manufacturer
  • Modelo / Serial
    Model Number FWD301 (US) & FDR301 (Non-US)   The following Lot Numbers on the packaged kits are affected: - 305000293250, 305000293251, 305000298616 (foreign)  The syringes within the packaged kits are also Lot numbered. For the packaged kit Lot Numbers above, the corresponding respective syringe Lot Numbers are:  - 10500028786, 105000288118, 105N00288965 (foreign)
  • Clasificación del producto
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Distribution and to the countries of and to the countries of Greece, France, Italy, Spain, Switzerland, South America, Turkey and United Kingdom.
  • Descripción del producto
    Integra¿ Flowable Wound Matrix || Size 3cc 1 unit/box || single use, sterile device Rx Only || Model Number FWD301 (US) & FDR301 (Non-US) || Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: || - An empty plastic syringe with Luer-Lok" tip || - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material || - A syringe-to-syringe Luer-Lok" adapter / connector || - A flexible plastic tube (injector) with Luer-Lok" connector || Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.
  • Manufacturer
  • Modelo / Serial
    Lot No. W1412086, Exp DEC-2017.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. || Used to administer steroid medication in the epidural space.
  • Manufacturer
  • Modelo / Serial
    W1404274, W1407165, W1409136, W1410082, W1412056, W1501065, W1501181
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. || Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.
  • Manufacturer
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