FDA Medical Device Recalls (openFDA)
Life Recovery Systems HD, LLC: 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
- Recall number
- Z-0456-2012
- 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
- Status
- Terminated
- Initiated
- 2011-10-21
- Posted
- 2012-01-11
- Terminated
- 2013-01-24
- Reason
- 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
- 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
- 28 units
- Distribution
- Nationwide Distribution including NY, NC, LA, NJ, AL. PA TX, KY, MO, MA, and TN
- Lot, serial or model codes
- 510 K K061023 N0110PD N0108NI N0068JH N0109PD N0103NE N0106NI N0065JH N0104NI N0105NI
- 510(k) numbers
- ["K061023"]
- PMA numbers
- not on file
- Product code
- NZE
- Firm FEI
- 3006059109
- Firm city
- Waldwick
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28