Events

Recall of Device Recall Arrow NextStep Antegrade Chronic Hemodialysis Catheter

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
    59212
  • Event Risk Class
    Class 1
  • Event Number
    Z-2883-2011
  • Event Initiated Date
    2011-06-28
  • Event Date Posted
    2011-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101741
  • 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
    Firm has received complaints indicating breakage and/or separation of the stylet within the arrow(r) nextstep(r) antegrade catheters.
  • Action
    An "Urgent Medical Device Recall" letter dated June 28, 2011 was issued to consignees. The letter requested that customers check their stock, cease use and distribution, and quarantine all affected product. Consignees were further directed to complete the "Recall Acknowledgement & Stock Status Form", return the form to their sales representative, and return affected product as instructed on the letter. For questions or concerns, call 1-800-233-3187.

Device

Device Recall Arrow NextStep Antegrade Chronic Hemodialysis Catheter
  • Model / Serial
    Product Number CS-15192-IXM, Lot Number RV1034909; Product Number CS-15232-IXM, Lot Number RV1034911; Product Number CS-15272-IXM, Lot Number RV1034912; Product Number CS-15312-IXM, Lot Number RV1034913; Product Number CS-15422-IX, Lot Number RV1034914; and Product Number CS-15502-IX, Lot Number RV1034915.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    United States (states of CA, DE, FL, MI, NC, and TN).
  • Product Description
    Arrow NextStep Antegrade Chronic Hemodialysis Catheter. || Product is used for 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