Events

Recall of Device Recall Tenderlett Adult Lancet

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by International Technidyne Corp.

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
    34461
  • Event Risk Class
    Class 2
  • Event Number
    Z-0673-06
  • Event Initiated Date
    2006-01-23
  • Event Date Posted
    2006-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43881
  • 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
    Lancet, Blood - Product Code FMK
  • Reason
    Some packages contained a pin-hole defect that permitted the transmission of dye through the primary packaging. this is a sterile product.
  • Action
    Recall letter was sent out 1/25/2006 via UPS tracking system per the distribution record addressees. With Cardinal Health, the letter was sent out to the firm''s corporate headquarters location.

Device

Device Recall Tenderlett Adult Lancet
  • Model / Serial
    Catalog No. TL100A and TL100I:  NL512; NL513; NL514; NL515; NL516; NL517; NL518; NL520; NL524; NL525; NL526; NL527; NN521; NP501; NP502; NP503; NP504.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed nationwide to medical supply distributors. The product was also shipped internationally to 3 countries: Canada, Czech Republic, and New Zealand. There are no Govt. accounts.
  • Product Description
    Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use.
  • Manufacturer
    International Technidyne Corp

Manufacturer

International Technidyne Corp
  • Manufacturer Address
    International Technidyne Corp, 23 Nevsky St, Edison NJ 08820-2425
  • Source
    USFDA