Events

Recall of Thermosuit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Life Recovery Systems HD, LLC.

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
    60636
  • Event Risk Class
    Class 2
  • Event Number
    Z-0456-2012
  • Event Initiated Date
    2011-10-21
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106096
  • 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
    Hypothermia monitor - Product Code NZE
  • Reason
    Thermosuit system model tsp-50 pump/controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading.
  • Action
    Life Recovery Systems sent recall letters/return response forms dated 10/24/2011 to all consignees. Life Recovery Systems has expanded their recall to include additional units and to provide additional service to products out in the field. A new recall letter was sent to consignees on 4/27/2012.

Device

Thermosuit
  • Model / Serial
    510 K K061023 N0110PD N0108NI N0068JH N0109PD N0103NE N0106NI N0065JH N0104NI N0105NI
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including NY, NC, LA, NJ, AL. PA TX, KY, MO, MA, and TN
  • Product Description
    ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA || Tel.: (973) 283-2800 || FAx.: (973) 283-2910 || Temperature reduction in patients where clinically indicated; Monitoring of patient temperature
  • Manufacturer
    Life Recovery Systems HD, LLC

Manufacturer

Life Recovery Systems HD, LLC
  • Manufacturer Address
    Life Recovery Systems HD, LLC, 150 Hopper Ave, Waldwick NJ 07463-1513
  • Manufacturer Parent Company (2017)
    Life Recovery Systems Hd Llc
  • Source
    USFDA