Events

Recall of Device Recall NeoPICC 1.9 FR 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
    30528
  • Event Risk Class
    Class 1
  • Event Number
    Z-0349-05
  • Event Initiated Date
    2004-11-24
  • Event Date Posted
    2005-01-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36060
  • 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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Reason
    Complaints of vessel erosion when using this product.
  • Action
    The recalling firm issued a letter dated 11/23/04 to physicians informing them of the increase in complaints for vessel erosion and one death (at that time). On 12/3/04, the recalling firm issued a press release to alert the medical community of the problem and the need to return the device. The recalling firm issued a recall letter dated 12/7/04, to the Director of Purchasing, informing them of the adverse events associated with the use of the product and the need to return all of their inventory.

Device

Device Recall NeoPICC 1.9 FR Catheter
  • Model / Serial
    All lots higher than number 3231
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The products were shipped to through specialty dealers/distributors to medical facilities nationwide. The product is also sold to government accounts and sales representatives. The product is also sold in Taiwan, Brazil, Hong Kong, Africia, and Canada.
  • Product Description
    NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. The product is shipped in cases of 5 units. Catalog numbers S1PIC1.9-S, S1PIC1.9-N, S1PIC1.9-SMK, and S1PIC1.9-C.
  • 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