Events

Recall of Device Recall Medline Industries Inc.

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
    74664
  • Event Risk Class
    Class 2
  • Event Number
    Z-2404-2016
  • Event Initiated Date
    2016-05-11
  • 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=148136
  • 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
    Container, liquid medication, graduated - Product Code KYW
  • Reason
    There is 5 ml printed next to the increment on the medicine cups instead of 10 ml. the cup has the correct ml markings for the other gradations, but sequentially, the markings are listed as 2.5 ml, 5 ml, 7.5 ml, and 5 ml.
  • Action
    Medline Industries sent a an URGENT RECALL letter dated 5/11/2016 to all affected consignees via certified mail. The URGENT RECALL letter described the reason for the recall and the actions to take.

Device

Device Recall Medline Industries Inc.
  • Model / Serial
    Lot Numbers 122211502  122212515
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Continental U.S.
  • Product Description
    Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
  • 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