Events

Recall of Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kendall Healthcare Products Co.

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
    32022
  • Event Risk Class
    Class 2
  • Event Number
    Z-0932-05
  • Event Initiated Date
    2005-04-27
  • Event Date Posted
    2005-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38941
  • 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
    Holes in thermoformed tray compromising the sterility of the product.
  • Action
    Visits by Tyco Sales Reps on 4/27 & 28/2005.

Device

Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Cathete...
  • Model / Serial
    158125 and 158128
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product shipped to hospitals in AZ, CA, IL, IN, NY, and TX.
  • Product Description
    Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Firm on label: Tyco Healthcare, Mansfield, MA. Product sold sterile, 10 units per case.
  • Manufacturer
    Kendall Healthcare Products Co

Manufacturer

Kendall Healthcare Products Co
  • Manufacturer Address
    Kendall Healthcare Products Co, 15 Hampshire St, Mansfield MA 02048-1113
  • Source
    USFDA