Events

Recall of Arrow PICC Kit with Blue Flex Tip Catheter and Placement Wire

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
    30089
  • Event Risk Class
    Class 2
  • Event Number
    Z-0551-05
  • Event Initiated Date
    2004-09-21
  • Event Date Posted
    2005-02-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35142
  • 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
    Product was mislabeled for lumen configuration, flow rates, and priming volume.
  • Action
    The recalling firm telephoned the hospital accounts on 9/21/04 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, a recall letter dated 9/21/04 was sent via FedEx to the hospitals.

Device

Arrow PICC Kit with Blue Flex Tip Catheter and Placement Wire
  • Model / Serial
    Lot numbers RF4088610 and RF4088406
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The products were shipped to hospitals in AZ, CA, NJ, and WV.
  • Product Description
    Arrow PICC Kit with Blue Flex Tip Catheter and Placement Wire. Catalog number PK-01552-WSSP
  • 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