Events

Recall of Device Recall ProLong

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Life-Tech International, 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
    26498
  • Event Risk Class
    Class 3
  • Event Number
    Z-1003-03
  • Event Initiated Date
    2001-05-09
  • Event Date Posted
    2003-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27779
  • 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
    Catheter does not fit through the needle resulting in delay of medical procedure.
  • Action
    The firm initiated the recall via letter to all consignees on May 9, 2001.

Device

Device Recall ProLong
  • Model / Serial
    All manufacturing codes were recalled.  Model numbers: PL-50, PL-100
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, MN, TX, FL, UT,
  • Product Description
    ProLong Continuous Nerve Block Set model nubers PL-50 and PL-100
  • Manufacturer
    Life-Tech International, Inc

Manufacturer

Life-Tech International, Inc
  • Manufacturer Address
    Life-Tech International, Inc, 4235 Greenbriar Dr, Stafford TX 77477-3995
  • Source
    USFDA