Events

Recall of Device Recall Deltec PortACath

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Deltec, 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
    28667
  • Event Risk Class
    Class 2
  • Event Number
    Z-0858-04
  • Event Initiated Date
    2004-03-29
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32695
  • 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, Catheter - Product Code DYB
  • Reason
    Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
  • Action
    A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.

Device

Device Recall Deltec PortACath
  • Model / Serial
    Lot M26890
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled products were shipped nationwide in the United States and worldwide.
  • Product Description
    6 Fr Introducer Set, REF 21-2320-24
  • Manufacturer
    Deltec, Inc

Manufacturer

Deltec, Inc
  • Manufacturer Address
    Deltec, Inc, 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA