Events

Recall of Portex Spinal

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Portex 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
    27470
  • Event Risk Class
    Class 2
  • Event Number
    Z-0166-04
  • Event Initiated Date
    2003-10-10
  • Event Date Posted
    2003-11-27
  • 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=29924
  • 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
    Spinal trays labeled as containing a whitacre 25g x 3.5' needle actually contain a quincke 25g x 3.5' needle.
  • Action
    Portex notified consignees on 10/10/03 by letter issued by Federal Express. Distributors were asked to supply customer list to Portex or to notify their accounts with copy of the recall letter provided.

Device

Portex Spinal
  • Model / Serial
    Lot number: K203631 Exp. Date: 2004-08
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Product Description
    Portex Spinal Tray with 25G Whitacre Needle. || Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine || Catalog Number: 15545-20
  • Manufacturer
    Portex Inc

Manufacturer

Portex Inc
  • Manufacturer Address
    Portex Inc, 10 Bowman Dr, Keene NH 03431-5043
  • Source
    USFDA