Events

Recall of Device Recall Arrow

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arrow International Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69938
  • Event Risk Class
    Class 2
  • Event Number
    Z-1007-2015
  • Event Initiated Date
    2013-02-04
  • Event Date Posted
    2015-01-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132005
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, hemodialysis, implanted - Product Code MSD
  • Reason
    The tunneling sheath packaged within the kits can crack during placement. if the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit.
  • Action
    An Urgent Medical Device Recall Notification letter, dated February 4, 2014, was sent to direct consignees that identified the product, problem, and action to be taken. Customers were asked to discontinue use and quarantine affected inventory. The Recall Acknowledgement form should be completed and faxed back to 1-800-343-2935. A customer service representative will contact customers with a Return Goods Authorization (RGA) Number and provide instructions for the return of the product. Customers are asked to contact their local sales representative or Customer Service at 1-800-343-2935 with questions.

Device

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
    Gastroenterology-Urology Devices
  • 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
    Arrow International Inc

Manufacturer

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