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U.S. Department of Health and Human Services

Class 2 Device Recall WarmAir Model 135 Convective Warming Device

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 Class 2 Device Recall WarmAir Model 135 Convective Warming Devicesee related information
Date Initiated by FirmJune 01, 2011
Date PostedJuly 27, 2011
Recall Status1 Terminated 3 on August 02, 2013
Recall NumberZ-2888-2011
Recall Event ID 59023
510(K)NumberK101148 
Product Classification Thermal Regulating System - Product Code DWJ
ProductWarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures through convective heat transfer from the controller to a warm-air heated blanket
Code Information 100V - Part Number: 86185; 115V - Part Number: 86186; and 230V - Part Number 86187.   Serial Numbers: 032-1351178 thru 104-1356908 and 104-1356910 to 104-1356915.   
FEI Number 1516825
Recalling Firm/
Manufacturer		 Cincinnati Sub-Zero Products Inc
12011 Mosteller Rd
Cincinnati OH 45241
For Additional Information Contact
513-772-8810
Manufacturer Reason
for Recall		Due to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket.
FDA Determined
Cause 2		Device Design
ActionCincinnati Sub-Zero Products, Inc. sent an 'URGENT Medical Device Recall Field Action Notice" dated July 12, 2011 to all affected customers. The letter includes: description of product, problem, and information to request a repair tubing kit free of charge. It also asks customers to complete and return a "Recall Response Form". For additional information e-mail WA135-2011@cszinc.com or call (800) 989-7373 or (513) 772-8810.
Quantity in Commerce5474 units
DistributionWorldwide Distribution: (USA) Nationwide, and the countries of Australia, Brazil, Bulgaria, Canada, Chile, Ecuador, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Taiwan, Thailand, The Netherlands, Turkey, U.A.E., UK, Uruguay, Venezuela, and Vietnam.
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 = DWJ
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