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
FDA Recall Z-0456-2012 · Posted 2012-01-11
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Recalling FirmLife Recovery Systems HD, LLC
Recall StatusTerminated
Product CodeNZE
Date Initiated2011-10-21
Date Terminated2013-01-24
Product Quantity28 units
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution including NY, NC, LA, NJ, AL. PA TX, KY, MO, MA, and TN
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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