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U.S. Department of Health and Human Services

Class 2 Device Recall BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850

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 Class 2 Recall
BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
see related information
Date Posted March 01, 2010
Recall Status1 Terminated on April 19, 2012
Recall Number Z-0895-2010
Recall Event ID 54487
Premarket Notification
510(K) Numbers
K053645  K060865 
Product Classification System, Thermal Regulating - Product Code DWJ
Product Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with either Bair Paws® Temperature Management Units: Models 850 and 875 Bair Hugger® Temperature Management Units: Models 500/OR, 505, 750 and 775 Indicated for hyper- or hypothermic patients or normothermic patients, for whom induced hyper- hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.
Code Information Part number 502221 Model 90024
Recalling Firm/
Manufacturer
Arizant Inc
10393 W 70th St
Eden Prairie, Minnesota 55344
Manufacturer Reason
for Recall
Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws¿ Temperature Management Units: Models 850 and 875 Bair Hugger¿ Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775 Ranger¿ Blood/Flui
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action An "Urgent Medical Device Power Cord Recall" letter dated December 17, 2009 was sent to customers. The letter was addressed to Recall Coordinator/Biomed Dept. The letter described the affected product, problem, hazard involved, and action to be taken by customer. The customers are being ask to inspect their temperature management units (as described in FDA's recommendation dated October 19, 2009) and contact the firm with the results of their inspection and provide a contact name via website www.arizant.com/powercords or phone (877) 947-1487. Replacement cords and instructions will be provided to customers based on priority listed in the letter and availability of replacement cords. If the customer does not have the means to make the changes, alternate means will be taken (i.e., an Arizant employee or outside service organizations may be brought in to do the replacements). If you have any questions, please contact the Aziant at (877) 47-1487.
Quantity in Commerce Total distributed for all devices: 84,537 US, 7,380 OUS.
Distribution Worldwide Distribution: USA and ARGENTINA, THE BAHAMAS, CANADA, COLOMBIA, COSTA RICA, CUBA, DOMINICAN REPUBLIC, ECUADOR, GERMANY, GUAM, JAPAN, LEBANON, MEXICO, NICARAGUA, PANAMA, PUERTO RICO, QATAR, SAUDI ARABIA, SOUTH KOREA, SURINAME , TAIWAN, TRINIDAD AND TOBAGO, QATAR.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWJ and Original Applicant = ARIZANT HEALTHCARE INC.
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