Events

Recall of Portex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD, 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
    29990
  • Event Risk Class
    Class 2
  • Event Number
    Z-0223-05
  • Event Initiated Date
    2004-09-09
  • Event Date Posted
    2004-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34921
  • 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
    Manometer, Spinal-Fluid - Product Code FMJ
  • Reason
    Sterility of the device is compromised due to packaging defects.
  • Action
    Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1. On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.

Device

Portex
  • Model / Serial
    Lot numbers starting with: 1, K1, K2, K50, K51, K52, K53
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Portex Hypodermic Needle-Pro 5 ml Syringe, || 22g x 1 ¿'' Needle || Catalog Number: 4254
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 10 Bowman Dr, Keene NH 03431-5043
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA