Events

Recall of Device Recall OneTouch Delica Lancing Device

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

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
    59078
  • Event Risk Class
    Class 2
  • Event Number
    Z-2835-2011
  • Event Initiated Date
    2011-05-27
  • Event Date Posted
    2011-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101053
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Lancet, blood - Product Code F MK
  • Reason
    Individuals attempting to remove a lancet from the onetouch delica lancing device without following instructions for use may experience an accidental needle stick.
  • Action
    Lifescan sent an Urgent Medical Device Correction letter dated May 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told that no action on their part is needed and were asked not to return any of the affected product. Customers were instructed to continue to distribute the product. Healthcare professionals and pharmacies were asked to share the information with their patients who use the OneTouch Delica Lancing Device. Patients with questions should contact Customer Care Line at 1-800-574-6138. For questions regarding this recall call 1-800-600-7226.

Device

Device Recall OneTouch Delica Lancing Device
  • Model / Serial
    Model Number 022-137-01
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada.
  • Product Description
    OneTouch Delica Lancing Device; || LifeScan Inc., Milpitas, CA || Testing of Blood Glucose Levels
  • Manufacturer
    Lifescan Inc

Manufacturer

Lifescan Inc
  • Manufacturer Address
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA