Events

Recall of Device Recall Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, PowderFree, Large Size

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
    57988
  • Event Risk Class
    Class 2
  • Event Number
    Z-1554-2011
  • Event Initiated Date
    2011-02-03
  • Event Date Posted
    2011-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97920
  • 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
    Vinyl patient examination glove - Product Code OIG
  • Reason
    The recall was initiated because the affected lot, lot number jcu004958569, of gloves did not meet the requirements for the water-leak test.
  • Action
    MEDLINE INDUSTRIES, INC. sent a RECALL NOTICE IMMEDIATE ACTION REQUIRED letter by US Mail on February 10, 2011, to all affected cusomters. The letter identified the product, the problem, and the action to be taken by the customer. The customers were instructed to: 1. Immediately quarantine ALL inventory of the affected lot for return to Medline. 2. Complete the attached recall verification form. Please complete this form EVEN IF you have none of the affected lot in stock. 3. Fax or email the completed form to Medline. The email address is Recalls@Medline.com or faxed the form to 866-767-1290. Customers with questions regarding the recall were instructed to contact Medline at 1-866-359-1704 or via e-mail at Recalls@Medline.com.

Device

Device Recall Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, PowderFree, Large...
  • Model / Serial
    Lot Number: JCU04958569
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including CA, HI, and NV.
  • Product Description
    Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Large Size, Catalog Number: MSV403P, Lot Number: JCU04958569
  • Manufacturer
    Medline Industries Inc

Manufacturer

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