Events

Recall of Central Lane, 34 weeks

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medline Industries 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
    71889
  • Event Risk Class
    Class 2
  • Event Number
    Z-2458-2015
  • Event Initiated Date
    2015-08-03
  • Event Date Posted
    2015-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139285
  • 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
    Central venous catheter tray (kit) - Product Code OFF
  • Reason
    The print plate artwork for this lot was found to state: central line <34 weeks kit displaying an incorrect sign in front of the 34. the description for this device should have stated central line >34 weeks kit. the defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks.
  • Action
    Medline Industries contacted the account directly via phone on August 4, 2015, they confirmed no affected product is in their facility. The lot numbers are easily identified on the outside of each kit. Second and third follow up communications will not be sent as we have confirmed the facility does not have any affected product. For questions regarding this recall call 847-643-4129.

Device

Central Lane, 34 weeks
  • Model / Serial
    Central Venous Catheter Kit for patients >34 weeks old with the coding below were affected.   Lot Numbers: 14DB9277 and 14PB2878 Unit No: DYNDC1987A Expiration Date: 06/2015  Serial No: N/A UPC code: N/A
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US including PA
  • Product Description
    Central Line >34 Weeks Kit. Cardiology department. || The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4485
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA