Device Recall Arrow

  • Model / 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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

140 devices with a similar name

Learn more about the data here

  • Model / Serial
    product number CDC-42802-P1A, lot number 23F14A0063
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    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
  • Model / 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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution US Nationwide, Canada and Mexico.
  • Product Description
    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
  • Model / 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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) and PR.
  • Product Description
    Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
  • Manufacturer
  • Model / Serial
    Lot Number: 18F14M0001
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Belgium
  • Product Description
    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
  • Model / Serial
    Lot Number: KF1111796 Exp. Date: 11/30/2013
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.
  • Product Description
    Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), || 8 Fr 40 cc || Model: IAB-05840-LWS
  • Manufacturer
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