Events

Recall of Device Recall Neolon 2G LatexFree PowderFree Neoprene Surgical Gloves

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terang Nusa Sdn Bhd.

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
    37013
  • Event Risk Class
    Class 2
  • Event Number
    Z-0365-2007
  • Event Initiated Date
    2006-12-18
  • Event Date Posted
    2007-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49759
  • 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
    surgical gloves - Product Code KGO
  • Reason
    Some of the packages labeled as latex-free actually contain latex gloves.
  • Action
    Terang Nusa telephoned Medline Industries on 12/13/06 requesting them to retrieve the affected lot of size six gloves from their customers. Medline Industries notified their customers by letter dated 12/20/06, informing them of the possible latex gloves being labeled as the Neolon 2G Neoprene Surgical Gloves, and requesting them to inspect their inventories for the suspect size and lot of gloves. The accounts were instructed to complete the enclosed response questionnaire, indicating the amount of affected gloves found, and fax it back to Medline at 847-949-2643 to obtain a return goods authorization. Any questions were directed to Kathy Dunne at 847-359-1704.

Device

Device Recall Neolon 2G LatexFree PowderFree Neoprene Surgical Gloves
  • Model / Serial
    Item number MDS207060, lot number T502554397, size 6
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide including USA, Canada, and Panama
  • Product Description
    Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malaysia
  • Manufacturer
    Terang Nusa Sdn Bhd

Manufacturer

Terang Nusa Sdn Bhd
  • Manufacturer Address
    Terang Nusa Sdn Bhd, 1, Jalan 8, Pengkalan Chepa 2, Ind Zone, Kota Bharu Malaysia
  • Source
    USFDA