Events

Recall of Device Recall NDI Combo Test Pak Omega 3

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

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
    57863
  • Event Risk Class
    Class 2
  • Event Number
    Z-0565-2012
  • Event Initiated Date
    2011-01-09
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105128
  • 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
    Container, specimen mailer and storage, sterile - Product Code KDT
  • Reason
    Kits contain recalled triad alcohol pads.
  • Action
    Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis. Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads. Users are to use the replacement wipes instead of the wipes contained in the kits. For any questions call (888)764-4120.

Device

Device Recall NDI Combo Test Pak Omega 3
  • Model / Serial
    All kits containing Triad alcohol prep pads
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Germany
  • Product Description
    NDI Combo Test Pak Omega 3, Product K7618, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. || Blood specimen collection
  • Manufacturer
    Heritage Labs International LLC

Manufacturer

Heritage Labs International LLC
  • Manufacturer Address
    Heritage Labs International LLC, 560 N Rogers Rd, Olathe KS 66062-1211
  • Source
    USFDA