Events

Recall of Device Recall Medline EZ Lubricating Jelly

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MEDLINE IND.

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
    75948
  • Event Risk Class
    Class 2
  • Event Number
    Z-0984-2017
  • Event Initiated Date
    2016-12-12
  • 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=151810
  • 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
    Lubricant, patient - Product Code KMJ
  • Reason
    Product was not sterilized. product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company.
  • Action
    Medline Industries sent a recall notification letters dated December 12, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to quarantine any affected product on hand and return product to Medline Industries for credit. Distributors were instructed to notify their customers and have them return affected product as well. For questions contact 866-359-1704.

Device

Device Recall Medline EZ Lubricating Jelly
  • Model / Serial
    Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AL, FL, GA, IA, IL, IN LA, MI, PA, TX, WI, and the country of Canada
  • Product Description
    Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). || Product Usage: || For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
  • Manufacturer
    MEDLINE IND

Manufacturer

MEDLINE IND
  • Manufacturer Address
    MEDLINE IND, 3 Lakes Dr, Northfield IL 60093-2753
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA