Device Recall Arrow

  • Modelo / Serial
    AP-06042 MF3075086  MF3075140  MF3085285
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed internationally (France, Germany, Mexico, United Kingdom, Singapore, Brazil, Australia) and domestically. Domestic distribution was concentrated in the Midwest and Eastern portions of the US. Total direct accounts : Distributors/dealers, international - 7 Distributors/dealers, domestic - 5 Hospitals, domestic -36 Approximate percentage of each type of consignee: Distributors/dealers, international - 14.6% Distributors/dealers, domestic - 10.4% Hospitals, domestic - 75% Percentage of product sent to each type of consignee : Distributors/dealers, international - 70.8% Distributors/dealers, domestic - 7.9% Hospitals, domestic - 21.3% No VA or government contracts.
  • Descripción del producto
    Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable (Product # AP-06042) [NB: titanium port]. || Product # AP-06042 kit contains 1 low profile implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), injection needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Arrow International Inc, 2 Berry Dr, Mount Holly NJ 08060-5017
  • Source
    USFDA

140 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot numbers: RF2095946, RF2056557, RF2058764, RF2060829,  RF2084897, RF2084162, RF2071325,RF2060831, RF2083836, RF2096027, RF2107409, RF2108329, RF2119933, RF2060836, RF2060899, RF2083837,  RF2084898, RF2107410, RF2108324, RF2071317, RF2121827, RF2058355,  RF2060414, RF2108326, RF2060811, RF2110441, RF2069798, RF2121821,  RF2069964, RF2122497, RF2110442, RF2058357, RF2119935, RF2108330,  RF2121820, RF2057719, RF2056545, RF2111259, RF2096348.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- US and Canada.
  • Descripción del producto
    The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, CS-15272-SFX, CS-15282-I, CS-15312-SFX, CS-15322-I, CS-15362-I, CS-15422-SFX, CS-15502-SFX, CS-15552-I, CSD-15242-I, CSD-15282-I, and CSD-15322-I. || The Arrow Edge Hemodialysis Catheterization Set and NextStep Antegrade Hemodialysis Catheterization Set is indicated for use in attaining long- term vascular access for hemodialysis and apheresis.
  • Manufacturer
  • Modelo / Serial
    product number CDC-42802-P1A, lot number 23F14A0063
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
  • Manufacturer
  • Modelo / Serial
    Product number AN-05501, Lot numbers: 23F13J0530, RF2108954, RF6127264, RF8045530, RF0021370, RF3014600, RF6127624, RF8070744, RF0035171, RF3026989, RF7031498, RF8083748, RF0050648, RF5084669, RF7043570, RF8096949, RF0075647, RF5094931, RF7088907, RF8123534, RF0092301, RF5106225, RF7090151, RF9015869, RF2021938, RF5118327, RF7102346, RF9030002, RF2044557, RF5120725, RF7113197, RF9071402, RF2058276, RF6081852, RF8018337, RF9098526, RF2083791, RF6092570, RF8020947, and RF9113319.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution US Nationwide, Canada and Mexico.
  • Descripción del producto
    ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.
  • Manufacturer
  • Modelo / Serial
    Product Codes: ASK-11142-MGH4, ASK-04020-UR1, CDC-45552-HPK1A, CDC-35052-VPS, ASK-09903-MGH3, CDC-02041-MK1A , CDC-45041-VPS,   ASK-09903-FAM, CDC-05052-HPK1A, NA-04020-X1A, CDC-21242-X1A,   ASK-04020-MI, ASK-04001-UOC, MSO-45703-AHS, CDC-45541-HPK1A ,   CDC-35052-HPK1A, ASK-21142-SG1, MSO-24703-AHS, MSO-29802-AHS, ASK-12702-SMCC, CDC-25142-X1A; Lot Numbers: 23F14H0501, 23F14J0287, 23F14J0619, 23F14J1390, 23F14H0918, 23F14J0613, 23F14J1433, 23F14K0115, 23F14J0617, 23F14J0356, 23F14K0114, 23F14J0554, 23F14J1134, 23F14J1551, 23F14J0508, 23F14J1142, 23F14J1516, 23F14J1355, 23F14H0577, 23F14J0237, 23F14H1120
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) and PR.
  • Descripción del producto
    Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
  • Manufacturer
  • Modelo / Serial
    Lot Number: 18F14M0001
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Belgium
  • Descripción del producto
    ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr || Product Code: IAB-05840-LWS || The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle
  • Manufacturer
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