Events

Recall of OneTouch SureSoft 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
    33941
  • Event Risk Class
    Class 2
  • Event Number
    Z-0271-06
  • Event Initiated Date
    2005-10-11
  • Event Date Posted
    2005-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42768
  • 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
    System, Test, Blood Glucose, Over The Counter - Product Code NBW
  • Reason
    In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks.
  • Action
    On October 11, 2005, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.

Device

OneTouch SureSoft Lancing Device
  • Model / Serial
    Part Number 021-139-01 OT SureSoft Hospital, Regular 200, Lot numbers, SW2764, SW3427, SW2779, SW2785, SW3339, SW3342, SW3394, SW3395.    Part number 021-140-01, OT SureSoft Hospital, Gentle 200, Lot numbers, SW2846, SW2833, SW2774, SW2868, SW2834, SW2765, SW2869, SW2894, SW2896.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to a total of 21 direct consignees and 45 end-user customers, for a total of 66 consignees in both the US and canada.
  • Product Description
    LifeScan OneTouch SureSoft Lancing Device, single use lancing device.
  • Manufacturer
    Lifescan Inc

Manufacturer

Lifescan Inc
  • Manufacturer Address
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035-6301
  • Source
    USFDA