Events

Recall of Device Recall Specimen Trap

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
    66775
  • Event Risk Class
    Class 2
  • Event Number
    Z-1612-2014
  • Event Initiated Date
    2013-11-04
  • Event Date Posted
    2014-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123381
  • 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
    Trap, sterile specimen - Product Code BYZ
  • Reason
    There is a potential that the specified mucus specimen traps are not sterile. use of the affected products may result in the contamination of patient specimens.
  • Action
    Medline sent a Recall Notification Letters dated November 4, 2013 to all affected customers.The letters included instructions for customers to: check their stock of the affected products; complete and return the enclosed response form even if none of the recalled products are in inventory; Medline will provide customers with a Return Goods Authorization upon receipt of the response form and credit will be issued upon receipt of the returned recalled products; and, notify any customers who may have received the recalled products. Customers who have any questions can contact Medline Industries at 866-359-1704.

Device

Device Recall Specimen Trap
  • Model / Serial
    Model Numbers: DYND44140, DYND44140H, and DYND44180;   Purchase Order Number: 4506595929
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of CA, MA, MD, MI, MN, NH, NJ, NY, OH, PA, TX, and UT.
  • Product Description
    Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual). Mucus Specimen Trap 80 cc, Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50). Used to collect mucus specimens during suction of fluid from the oral cavity, nose-throat area and/or bronchi of a patient.
  • 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