Events

Recall of MEDLINE COUBLE SWIVEL CLOSED SUCTION CATHETER

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
    78319
  • Event Risk Class
    Class 2
  • Event Number
    Z-0113-2018
  • Event Initiated Date
    2017-10-10
  • Event Date Posted
    2017-11-18
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159166
  • 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
    Catheters, suction, tracheobronchial - Product Code BSY
  • Reason
    Products labeled as sterile were distributed prior to sterilization.
  • Action
    The recall was initiated by mail on 10/10/2017. The letter contained the following directive: "REQUIRED ACTION: 1. Immediately check your stock for item numbers DYNCPE8 (Lot 2861707008) & DYNCSDS12 (Lot 28617070015) place them on hold and complete the attached response form. Quarantine all affected product / lots. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the response form. When we receive your completed response form you will be sent return labels (if applicable). Your account will receive credit when the returned product is received. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, Inc. If you have any questions, please contact 866-359-1704."

Device

MEDLINE COUBLE SWIVEL CLOSED SUCTION CATHETER
  • Model / Serial
    Lot 28617070015
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    FL, IN, TN, GA, NJ, UT, MD, Nicaragua, Honduras
  • Product Description
    MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, Three Lakes Drive, Northfield IL 60093
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA