Events

Recall of Device Recall Deltec branded PORTACATH II

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical MD, 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
    30512
  • Event Risk Class
    Class 2
  • Event Number
    Z-0442-05
  • Event Initiated Date
    2004-11-11
  • Event Date Posted
    2005-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36025
  • 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
    Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
  • Reason
    The catheter became disconnected from the port while implanted in the patient.
  • Action
    USA consignees were contacted by telephone on 11/11/04. The international consignees were e-mailed and telephone contacted on 11/11/04. The Customer Recall Notification Letter was mailed or faxed on 11/16/04. Customers were asked to inspect their inventory for the affected recall lot and then requested to return any unused product to Smiths Medical. As a result of the recall, some customers may be affected by product unavailability. Smiths'' is endeavoring to have product available as soon as possible. For implanted product it is essential to confirm portal and catheter integrity as described in the Instructions for Use supplied with the product before any injection or infusion therapy.

Device

Device Recall Deltec branded PORTACATH II
  • Model / Serial
    M36262
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    To 11 facilities in FL, GA, ME, MN, NH, NJ, OK, TX, WI, WV and Peurto Rico. And to 2 international distributors (Canada and Taiwan).
  • Product Description
    Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow, Ployurethane Catheter, 2.6 mm (7.8 Fr) O.D. x 1.6 mm I.D., 8.5 Fr Introducer Set. Immediate package states Contents of unopened and undamaged individual product packages are STERILE and non-pyrogenic. Check package integrity before use. Destroy after use. Do not resterilize. Latex free. Deltec, Inc. 1265 Grey Fox Road, St. Paul, MN 55112
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • Manufacturer Address
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA