Device Recall Integra

  • Modelo / Serial
    Panta Nails -  Reference/Model #500050ND - Lot #'s: F33A, F33B, F3BN, F3Y5, F3Y6, F4S4, F56Y, F5LZ, F64W, F7C8, F7C9, F8SZ, F9PC, FCUG, FCUH, FEDW, FEVR, FGAX, FGLN and FHLP;  Reference/Model #500080ND - Lot #'s: F0F1, F64X, F81Y, F81Z, FEVS, FGLP and FGSK;  Reference/Model #500150ND - Lot #'s: F15L, F15L/1, F1ZQ, F27U, F27V, F3Y7, F5M0,F60W, F64Y, F64Z, F6L3, F7CA, F7CB, F7CC, F7CD, F821, F822, F8T1, F8T2, F9D6, F9D7, FEDX, FFB9, FG4T, FGSL and FHLR;  Reference/Model #500180ND - Lot #'s: F1ZS, F33C, F3M9, F4H4, F4ZZ, F68B, F823, F824, F8T3, FDEC, FEDY, FFBA and FFQL;  Reference/Model #500250ND - Lot #'s: EP14, F0WQ, F15M, F4H5, F500, F5M1, F650, F825, F826, F827, F828, F8T4, FGLQ and FGSM;  Reference/Model #500280ND - Lot #'s: F27T, F33D, F3BP, F3MA, F4H6, F5M2, F6L4, F829, F82A, F82B, F82C, F8T5 and FFBB;  Reference/Model #500350ND - Lot #'s: E2W1/1, F3BQ, F3MB, F3MD, F3Y8, F4H7, F5M3, F651, F6TT and FF3B;  Reference/Model #500380ND - Lot #'s: F3BR, F3MC, F4S5, F5M4, F60X, F652, F82D, F82E, F8T6 and FAF2  Panta XL Nails -  Reference/Model #510111ND - Lot #'s: F3H8, F4XA, F507, F5M5, F68C, F82F, F82G, F8T7, F9DC and F9DD;  Reference/Model #51014ND - Lot #'s: ELSS, EPFZ, F3H9, F82H, F82J, F8LG, FEVT and FFBC;  Reference/Model #510211ND - Lot #'s: F6JA, F82K, F82L, F8C8, F8T8, FFQN and FG4V;  Reference/Model #510241ND - Lot #'s: F5M6, F82M, F82N, F8C9 and F8T9;  Reference/Model #510311ND - Lot #'s: EPG0/1, EPG0/2, EPG0/3, EPG0/4, EPG0/5, F82P, F82Q and F8TA;  Reference/Model #510341ND - Lot #'s: F4H8, F508, F657 and F8TB
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide and Internationally
  • Descripción del producto
    Panta Nail, Rx only, Sterile,
  • 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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