Events

Recall of Arrow central venous catheterization kit, 14 ga x 20 cm

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
    27415
  • Event Risk Class
    Class 3
  • Event Number
    Z-0083-04
  • Event Initiated Date
    2003-09-16
  • Event Date Posted
    2003-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29838
  • 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, Syringe Needle - Product Code KZH
  • Reason
    Wrong product in box.
  • Action
    The recalling firm issued a recall letter to their direct customers dated 9/16/03. The recall letter explained the reason for recall and to return the product.

Device

Arrow central venous catheterization kit, 14 ga x 20 cm
  • Model / Serial
    Catalog number AK-04700, Lot number RF3067086
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to distributors in AL, AZ, CA, CO, FL, HI, IL, IN, KS, MD, MI, MN, MO, NC, NM, NY, OH, PA, TN, TX, VA, and WI. The products were shipped to government accounts in AZ, AK, DC, IN, SC, and VA. The products were shipped to hospitals nationwide.
  • Product Description
    Arrow central venous catheterization kit, 14 ga x 20 cm
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605
  • Source
    USFDA