Events

Recall of Device Recall 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
    29490
  • Event Risk Class
    Class 2
  • Event Number
    Z-1266-04
  • Event Initiated Date
    2004-07-02
  • Event Date Posted
    2004-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33988
  • 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
    Anesthesia Conduction Kit - Product Code CAZ
  • Reason
    Trays contain hospira recalled 2ml drug ampuls of 5% lidocaine hydrochloride with 7.5% dextrose injection, (ndc 0074-4712-01, lot number 09-568-dk) hospira, inc. was recalling the 2ml drug vials of 5% lidocaine hydrochloride w/ 7.5% dextrose lot number 09-568-dk). the drug is being recalled due to reports of particulate in the product.
  • Action
    Smiths Medical notifed Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004. Customers and dealers are directed to fax back the attached Reply Letter

Device

Device Recall Portex
  • Model / Serial
    Lot Number: K519322
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    15963-20 SPINAL(DD) 22G WHITACRE W/DRUGS
  • 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