Events

Recall of Device Recall Positive Touch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Henry Schein, 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
    26594
  • Event Risk Class
    Class 2
  • Event Number
    Z-1046-03
  • Event Initiated Date
    2003-06-27
  • Event Date Posted
    2003-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28182
  • 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
    Fda's analysis revealed defects (holes) in the latex gloves.
  • Action
    Recall letters were faxed to the 5 end users on 6/27/03. This was followed up with phone calls to the 5 end users. Recall letters were faxed and mailed to all 18 end users on 7/10/03, advising them of the recall expansion.

Device

Device Recall Positive Touch
  • Model / Serial
    Reorder No. 8878. All lots distributed between May 28, 2003 and July 9, 2003.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    18 end users in NY, NJ, PA, MA, CT, NH, ME, MD, VA.
  • Product Description
    Positive Touch (TM) SMOOTH POWDER-FREE LATEX EXAM GLOVES, LARGE. REORDER NO. 8878. Single Use Only. Qty. 100 Per Box (50 pairs), 1000 Per Case. || Firm on label - Allegiance Healthcare Corporation, McGraw Park, IL 60085 USA (Allegiance a Cardinal Health company). Made in Malaysia.
  • Manufacturer
    Henry Schein, Inc.

Manufacturer

Henry Schein, Inc.
  • Manufacturer Address
    Henry Schein, Inc., 135 Duryea Road, Melville NY 11747
  • Source
    USFDA