Events

Recall of Device Recall One Touch 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
    38035
  • Event Risk Class
    Class 2
  • Event Number
    Z-1165-2007
  • Event Initiated Date
    2007-03-30
  • Event Date Posted
    2007-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52818
  • 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
    Lancing Device - Product Code FMK
  • Reason
    Lancet tip may not fully retract and cause needle stick and exposure to used lancets.
  • Action
    The firm has conducted a health hazard evaluation, and has initiated a corrective action plan. The firm initated recall on March 30, 2007, and notifications were sent to hospital end users known to Lifescan and its direct accounts. In addition, a customer service script has been developed to address any questions from incoming users. The firm has requested direct accounts to perform subrecalls on Lifescan's behalf to notify customers of the recall as needed.

Device

Device Recall One Touch SureSoft Lancing Device
  • Model / Serial
    Lot SA4426; Part number 021-140-01
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed nationwide to distributors and wholesale dealers.
  • Product Description
    One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200
  • Manufacturer
    Lifescan Inc

Manufacturer

Lifescan Inc
  • Manufacturer Address
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035-6312
  • Source
    USFDA