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U.S. Department of Health and Human Services

Class 2 Device Recall Thermosuit

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 Class 2 Device Recall Thermosuitsee related information
Date Initiated by FirmOctober 21, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on January 24, 2013
Recall NumberZ-0456-2012
Recall Event ID 60636
510(K)NumberK061023 
Product Classification Hypothermia monitor - Product Code NZE
ProductThermoSuit 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 510 K K061023 N0110PD N0108NI N0068JH N0109PD N0103NE N0106NI N0065JH N0104NI N0105NI
Recalling Firm/
Manufacturer		 Life Recovery Systems HD, LLC
150 Hopper Ave
Waldwick NJ 07463-1513
For Additional Information ContactMr. Robert Schock, PhD
973-283-2800
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionLife 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 Commerce28 units
DistributionNationwide Distribution including NY, NC, LA, NJ, AL. PA TX, KY, MO, MA, and TN
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NZE
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