Events

Recall of Device Recall Zee Clear Vinyl Medical Examination Gloves, XLarge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cypress Medical Products LLC.

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
    60552
  • Event Risk Class
    Class 2
  • Event Number
    Z-0681-2012
  • Event Initiated Date
    2011-11-15
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105792
  • 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
    The gloves fail to meet the performance requirements of 21 cfr 800.20 for leakage defects.
  • Action
    Cypress Medical telephoned the accounts and then sent Urgent Voluntary Medical Device Recall letters dated November 14, 2011, to all affected customers. The letter informed them that the lot of gloves did not meet certain release specifications and that some of the gloves may not provide an effective barrier to infectious material. Customers were requested to cease distribution of the affected product, quarantine the gloves, and contact Cypress Medical's customer service department at 800-334-3646 for a returned goods authorization, return instruction and credit. The accounts were also requested to notify their customers of the recall, and to complete and return the enclosed reply form. For questions regarding this recall call 815-385-0100.

Device

Device Recall Zee Clear Vinyl Medical Examination Gloves, XLarge
  • Model / Serial
    Zee Part No.: 3063, lot number CZA04-22
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including California, Indiana, New York and Texas
  • Product Description
    Zee Clear Vinyl Medical Examination Gloves, Powder Free, X-Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3063 || Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants
  • Manufacturer
    Cypress Medical Products LLC

Manufacturer

Cypress Medical Products LLC
  • Manufacturer Address
    Cypress Medical Products LLC, 1202 S Il Route 31, Mchenry IL 60050
  • Manufacturer Parent Company (2017)
    Mckesson Corporation
  • Source
    USFDA