Events

Recall of Device Recall Introcan Safety IV Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Braun,B Medical 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
    28912
  • Event Risk Class
    Class 2
  • Event Number
    Z-1092-04
  • Event Initiated Date
    2004-03-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32787
  • 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
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
  • Reason
    Mislabeled product. the recalling firm received a complaint that a box of introcan safety catheters, (22g x 1 inch) contained mixed 18g catheters with the same lot number.
  • Action
    The recalling firm received a product complaint of a mixed 18G Catheters with 22G Catheters.

Device

Device Recall Introcan Safety IV Catheter
  • Model / Serial
    Catalog Number is 4253540 and the lot numbers are 3G26258U02 and 3G27258U02
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The affected recalling units were distributed nationwide to the following states: AZ, CA, GA, IL, IN, MD, OH, OK, OR, MA, MI, NC, NJ, NY, OR, PA, TX, UT, VA, WI
  • Product Description
    Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot numbers: || Catalog Number 4253540 - Lot number 3G26258U02 || Catalog Number 4253540 - Lot number 3G27258U02
  • Manufacturer
    Braun,B Medical Inc

Manufacturer

Braun,B Medical Inc
  • Manufacturer Address
    Braun,B Medical Inc, 901 Marcon Blvd, Allentown PA 18109-9512
  • Source
    USFDA