Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), medical and surgical floors, or any other department or hospital facility requiring patient temperature management. To prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. Used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air heated blanket.
FDA Recall Z-3119-2011 · Posted 2011-09-01
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Recalling FirmCincinnati Sub-Zero Products Inc
Recall StatusTerminated
Product CodeDWJ
Date Initiated2011-07-20
Date Terminated2013-07-05
Product Quantity6561 units were distributed.
Reason for Recall
Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling regulations.
Firm Action
Cincinnati Sub-Zero Products, Inc. sent an 'URGENT Medical Device Recall Field Action Notice" dated July 27, 2011, to all affected user/customers. The letter includes: description of device; the problem with the suspect manuals, and provides contact information for the customers to use to request new versions of the manuals. Upon receipt of the new manuals, the customers are asked to immediately collect and destroy/discard all of the old manuals at their facility and to replace them with the new versions. After the manuals have been discarded and replaced, the customers are asked to complete and return the attached "Recall Response Form" via fax to (513) 772-9119 or scan and email to [email protected] or mail to Cincinnati Sub-Zero, 12011 Mosteller Road, Cincinnati, OH 45241.
For additional information the customers are provided with an e-mail address: [email protected] as well as a toll-free telephone number and fax number to reach the firm and obtain additional information as necessary. The contact numbers are: 1 (800) 989-7373, or (513) 772-8810, and/or fax # (513) 772-9119..
Root Cause
Labeling design
Distribution Pattern
Nationwide distribution: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
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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