Events

Recall of Device Recall Phantom black latex powderfree gloves

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Adenna 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
    60894
  • Event Risk Class
    Class 2
  • Event Number
    Z-0712-2012
  • Event Initiated Date
    2011-12-22
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106728
  • 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
    Latex patient examination glove - Product Code LYY
  • Reason
    The recall was initiated because adenna inc. distributed latex gloves that have been fda refused.
  • Action
    Adenna Inc. sent a recall letter dated December 22, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to examine their inventory and quarantine the products that are subject to the recall. Customers were instructed to notify their customers if they have further distributed the products. Customers were instructed to cease using the recalled products, and Adenna will replace the products. Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with any questions can contact their account manager at (888) 3ADENNA (1-888-323-3662) for futher assistance.

Device

Device Recall Phantom black latex powderfree gloves
  • Model / Serial
    Lot No. 002-E1LF302-1 and Lot No. 002-E1LF305-1
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of: FL, CA, NY, NV, NC, MD, TX, OR, AZ, OH, MN, and IL.
  • Product Description
    Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium, || Product Code PHM912, Lot No. 002-E1LF302-1, Manufacture date JUL 2011, Size Small || Product Code PHM915, Lot No. 002-E1LF305-1, Manufacture date JUL 2011, Size Medium || Examination Disposable Gloves
  • Manufacturer
    Adenna Inc

Manufacturer

Adenna Inc
  • Manufacturer Address
    Adenna Inc, 201 S Milliken Ave, Ontario CA 91761-7832
  • Manufacturer Parent Company (2017)
    Adenna Inc.
  • Source
    USFDA