Events

Recall of Device Recall Virotek SAFELET 2.0 mm Safety Lancets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Efoora, Inc. dba Virotek, L.L.C..

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
    31966
  • Event Risk Class
    Class 2
  • Event Number
    Z-0905-05
  • Event Initiated Date
    2005-05-05
  • Event Date Posted
    2005-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38827
  • 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
    The sterility of the lancets may be compromised due to inadequate packaging seals.
  • Action
    Efoora/Virotek sent recall notifications to their customers via fax and DHL delivery on 5/5/05 through 5/27/05. The accounts were informed that the sterility of the lancets had been compromised due to inadequate seals. The accounts were requested to check their inventories for the affected lots, discontinue their use/distribution, and return the product to Efoora for a refund. Any questions were directed to Mary Hill, Director of Quality Assurance at 847-634-4500, ext. 277.

Device

Device Recall Virotek SAFELET 2.0 mm Safety Lancets
  • Model / Serial
    stock code 5000052, 5000101and 5000115, lot numbers 0018, 0023, 0024, 0025, 0026, 0027, 0028
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally to Australia, Belgium, Bolivia, Colombia, Finland, Israel, Italy, Japan, Mexico, Nigeria, Russia, Singapore, South Africa, Spain, Sweden, Taiwan, Trinidad, United Kingdom and Zimbabwe.
  • Product Description
    Virotek SAFEL*E*T 2.0 mm Safety Lancets, 2.0 mm depth, stock code 5000052, packaged in single unit blister packs, 200 per box, 6 boxes per carton, stock code 5000101, packaged in single unit blue cap packaging, 100 per box, and stock code 5000115, packaged in single unit blue cap packaging, 200 per box; Virotek, L.L.C., 900 Asbury Dr., Buffalo Grove, IL 60089
  • Manufacturer
    Efoora, Inc. dba Virotek, L.L.C.

Manufacturer

Efoora, Inc. dba Virotek, L.L.C.
  • Manufacturer Address
    Efoora, Inc. dba Virotek, L.L.C., 900 Asbury Dr, Buffalo Grove IL 60089-4557
  • Source
    USFDA