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
    27681
  • Event Risk Class
    Class 3
  • Event Number
    Z-0257-04
  • Event Initiated Date
    2003-11-04
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30602
  • 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
    Introducer, Catheter - Product Code DYB
  • Reason
    The 9.6 fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.
  • Action
    The firm began notification of consignees via U.S. mail on 11/4/03. A notice of the recall was also posted on the firm''s website (search for 'recall').

Device

Device Recall Arrow
  • Model / Serial
    AP-06022 MF3075080  MF3085227  MF3085410
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. || Introducer Kit Implantable Vascular Access System (Product # AP-06022) [NB: || plastic port] || Product # AP-06022 kit contains 1 low profile implantable plastic 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), straight non-coring needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Manufacturer Address
    Arrow International Inc, 2 Berry Dr, Mount Holly NJ 08060-5017
  • Source
    USFDA