Events

Recall of Langston Dual Lumen Catheters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vascular Solutions, 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
    56709
  • Event Risk Class
    Class 2
  • Event Number
    Z-2608-2010
  • Event Initiated Date
    2010-09-02
  • Event Date Posted
    2010-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94333
  • 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, diagnostic - Product Code DQO
  • Reason
    Investigation of a recent device experience report has made us aware of a potential problem with our 6f langston dual lumen pigtail catheter (model 5540) with the following lot numbers: 548110, 548227, 548364, 548430, 548554 & 548723. recently, it was reported that pouches containing langston pigtail catheter (model 5540) were missing a seal, posing a risk of product contamination. it is possib.
  • Action
    Consignees were sent on 9/2/10, a Vascular Solutions "Urgent Medical Device Field Action" letter dated September 1, 2010. The letter was addressed to Cath Lab Manager. The letter descried the product and the problem. Provided instructions to examine pouches of opened boxes to see if they have not been sealed. If unsealed, they recommended to remove pouches from the current inventory. For unopened boxes they recommended to remove the boxes from the inventory. Requested consignees to complete the Field Action Customer Inventory Form included with the letter. For any questions, please contact the firm at 763-656-6032.

Device

Langston Dual Lumen Catheters
  • Model / Serial
    Lot 548110, 548227, 548364, 548430, 548554, and 548723.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS,MO, NE, NY,NH, NJ, NM, NY,NC, OH, OK, OR, A, PR, SC, TN, TX, UT, VA, WA, WV, WI, and WY. SINGAPORE, MEXICO, CANADA, SPAIN, AUSTRIA, GERMANY, ITALY, ENGLAND, and SWITZERLAND.
  • Product Description
    Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore Court, Minneapolis, MN 55369, 110 cm length, || Usage: Indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites, This type of pressure measurement is useful in determining transvalvular, intravascular and interventricular pressure gradients.
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.
  • Manufacturer Address
    Vascular Solutions, Inc., 6464 Sycamore Ct, Maple Grove MN 55369-6032
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA