Events

Recall of Device Recall Triumph LT 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
    35609
  • Event Risk Class
    Class 2
  • Event Number
    Z-1185-06
  • Event Initiated Date
    2006-05-23
  • Event Date Posted
    2006-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46464
  • 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
    Surgeon'S Gloves - Product Code KGO
  • Reason
    The sterile glove pouches may have an open seal at the bottom of the pouch.
  • Action
    Terang Nusa notified Medline Industries via letters dated 5/23/06 and 5/26/06 to cease distribution of the gloves due to the defective seals on the pouches, and retrieve the affected lot of size seven gloves from their customers. Medline Industries notified their customers by letter dated 6/1/06, informing them of the possible open seals on the packages of surgeon''s 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 847-970-4678.

Device

Device Recall Triumph LT Surgical Gloves
  • Model / Serial
    Item number MDS108070LT, lot number T502504322, size 7
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes per carton; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malayia
  • 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