Events

Recall of McKesson Powder Free Vinyl Exam Gloves

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

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
    75638
  • Event Risk Class
    Class 2
  • Event Number
    Z-0741-2017
  • Event Initiated Date
    2016-10-12
  • Event Date Posted
    2016-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150974
  • 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 LYZ
  • Reason
    A container of mckesson vinyl gloves that failed the fda leak test was inadvertently distributed.
  • Action
    A letter, dated October 19, 2016, on Cypress Medical Products letterhead, was sent to customers. Customers were requested to stop use and quarantine the gloves.

Device

McKesson Powder Free Vinyl Exam Gloves
  • Model / Serial
    Lot Number: CDZF06-03
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution. This recall is limited to one distribution center in Auburn, Washington, and the customers serviced from that distribution center.
  • Product Description
    McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
  • Manufacturer
    CYPRESS MEDICAL PRODUCTS

Manufacturer

CYPRESS MEDICAL PRODUCTS
  • Manufacturer Address
    CYPRESS MEDICAL PRODUCTS, 9954 Mayland Dr Ste 4000, Richmond VA 23233-1464
  • Manufacturer Parent Company (2017)
    Mckesson Corporation
  • Source
    USFDA