ThermoSuit Manufactured for Life Recovery Systems. HD, LLC… recallZ-0456-2012 · Life Recovery Systems HD, LLC · initiated Oct 21, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Life Recovery Systems HD, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0456-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 21, 2011
- Posted by the FDA
- Jan 11, 2012
- Recalling firm
- Life Recovery Systems HD, LLC
- Quantity
- 28 units
- Product code
- NZE
- FDA submissions
- K061023
- 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
Code information (models, lots, serial numbers)
510 K K061023 N0110PD N0108NI N0068JH N0109PD N0103NE N0106NI N0065JH N0104NI N0105NI
Other devices under the same FDA submission
1 device cleared under K061023 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ThermoSuit System TSP-50 Pump/ControllerLife Recovery Systems Hd LLC · Hyperthermia Monitor1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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