Events

Recall of 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
    36522
  • Event Risk Class
    Class 2
  • Event Number
    Z-0276-2007
  • Event Date Posted
    2006-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48834
  • 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
    Implantable Vascular Access System - Product Code LJT
  • Reason
    Catheter has separated from the infusion port body.
  • Action
    The recall notification was sent out to their US customers on 9/29/2006.

Device

Arrow
  • Model / Serial
    Product No. AP-06046. Lot Number: MF2102346, MF2112623, MF2122946, MF3023531, MF3043934, MF3074943, MF3085287, MF3095692, MF4020550, MF4031019, MF4031353, MF4041638, MF4063174, MF4105485, MF5017413, MF5017546, MF5038769.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. The firm is NOT recalling from international accounts.
  • Product Description
    Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free Low Profile B Port, 6 Fr. Introducer Kit. || Ref Product No. AP-06046
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA