Device Recall Integra

  • Modèle / numéro de série
    Model #'s 19700 and 19700ND
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution
  • Description du dispositif
    Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment || The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon ruptures: Acute rupture of the Achill tendon(<10 days); Rupture located between 2 and 8 cm above calcaneum; Open or closed ruptures
  • Manufacturer
  • 1 Event

Fabricant

85 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    H13L22013
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US (nationwide) Distribution.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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)
  • Classification du dispositif
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lot No. W1412086, Exp DEC-2017.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    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
  • Modèle / numéro de série
    W1404274, W1407165, W1409136, W1410082, W1412056, W1501065, W1501181
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    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
80 en plus