Events

Recall of Device Recall Life Sync Leadwear Disposable

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GMP Companies/Lifesync Corporation.

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
    37252
  • Event Risk Class
    Class 2
  • Event Number
    Z-0546-2007
  • Event Initiated Date
    2007-01-10
  • Event Date Posted
    2007-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50198
  • 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
    ecg component - Product Code DRG
  • Reason
    When the v-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. if the product is used during a defibrillation after such a de-lamination, it could burn the skin and may compromise the efficacy of the defibrillation.
  • Action
    The recall was initiated on January 15, 2007. The firm''s representatives, hand carried, Device Recall Letter to Account Representative and Risk Manager. Distributors who received the Device Recall Letter, purged their stock of the affected devices and notified their customers. Recall Communication was hand carried to each account with 100% compliance by LifeSync Clinical/Sales Personnel. EFFECTIVENESS CHECKS of this recall will be achieved through Return Material Authorization via telephone with each affected account.

Device

Device Recall Life Sync Leadwear Disposable

Manufacturer

GMP Companies/Lifesync Corporation
  • Manufacturer Address
    GMP Companies/Lifesync Corporation, One E. Broward Blvd., Suite 1701, Ft Lauderdale FL 33301
  • Source
    USFDA