Events

Recall of lifecel

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

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
    45819
  • Event Risk Class
    Class 2
  • Event Number
    Z-0521-2008
  • Event Initiated Date
    2007-09-03
  • Event Date Posted
    2008-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66212
  • 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
    Battery-Defibrillator - Product Code MKJ
  • Reason
    Marketed without a 510k.
  • Action
    The original recall communication was sent out on 9/3/07 by Phoenix Solutions, a consultant to Battery Zone, as a Dear Valued Customer notice. A second recall communication, Urgent Device Recall Letter, was issued by Exxocom Technology Group dated 10/25, was sent out to all customer (even those who had returned product) on 11/5/07. Both communication were sent by first class mail, requesting return of batteries

Device

lifecel
  • Model / Serial
    All Serial Numbers
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide-Batteries were distributed to dealers or distributors in CT, GA, MN, NC, NY, OH, OK, OR, PA and TN plus one Canadian Consignee
  • Product Description
    life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N:9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.
  • Manufacturer
    Exocomm Tech Grp

Manufacturer

Exocomm Tech Grp
  • Manufacturer Address
    Exocomm Tech Grp, 1874 Catasauqua Rd, Allentown PA 18109-3128
  • Source
    USFDA