Z-0456-2012

ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA Tel...

Name: Z-0456-2012 ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA Tel...
Creator: Life Recovery Systems HD, LLC
Published: 2011-10-21
License: https://open.fda.gov/license/

Life Recovery Systems HD, LLC / initiated 2011-10-21 / Terminated / root cause: manufacturing process

FDA source

Life Recovery Systems HD, LLC began a recall of ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA Tel.: (973) 283-2800 FAx.: (973) 283-2910 Temperature... on 2011-10-21. The reason FDA records is "ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0456-2012
Status: Terminated
Initiated: 2011-10-21
Posted: 2012-01-11
Terminated: 2013-01-24
Recalling firm: Life Recovery Systems HD, LLC
Product: 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
Product code: NZE Hyperthermia Monitor
Reason for recall: ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 28 units
Distribution: Nationwide Distribution including NY, NC, LA, NJ, AL. PA TX, KY, MO, MA, and TN
Product codes and lots: 510 K K061023 N0110PD N0108NI N0068JH N0109PD N0103NE N0106NI N0065JH N0104NI N0105NI

Product code NZE

K061023Class IIThermosuit SystemLife Recovery Systems Hd, LLC / cleared 2006-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)