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U.S. Department of Health and Human Services

Class 2 Device Recall 115V Blanketroll III Model 233 and 115V CoolBlue Model 2501

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  Class 2 Device Recall 115V Blanketroll III Model 233 and 115V CoolBlue Model 2501 see related information
Date Initiated by Firm October 18, 2010
Date Posted March 30, 2011
Recall Status1 Terminated 3 on March 08, 2013
Recall Number Z-1817-2011
Recall Event ID 57004
510(K)Number K101589  
Product Classification Thermal Regulating System - Product Code DWJ
Product 115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000.

Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.
Code Information Model 233, Serial Numbers 061-3-00001 through 101-3-01389 and Model 25-01, Serial Numbers 073-CB-00001 through 094-CB-00138.
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		 The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeling regulations.
FDA Determined
Cause 2		 Other
Action On 10/18/2010 & 11/5/2010 the firm sent URGENT Medial Device Field Action letters, dated 10/18/2010, to their customers. The letters identified the affected product and stated the reason for recall. Customers were instructed to immediately collect and discard all affected product Operation and Operation/Technical Service manuals currently in their possession. They were to replace all the discarded manuals with the revised versions that were provided with the letter. The enclosed response form should be completed and returned by fax to 513-772-9119, scanned and e-mailed to B3manual@cszinc.com. If the product had been further distributed, then those customers should also be identified and notified of the field action via a copy of the letter. Customers should direct questions to the field action coordinator, David Niehaus at 513-773-8810 ext. 3234.
Quantity in Commerce 763 - 115V Blanketrol III Model 233; & 133 - 115V CoolBlue Model 25-01
Distribution Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, & WI and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CHILE, CROATIA, ECUADOR, EL SALVADOR, GERMANY, HONG KONG, INDONESIA, ISRAEL, ITALY, KOREA, MALAYSIA, MEXICO D.F., NEW ZEALAND, PEOPLE'S REPUBLIC OF CHINA, PERU, REPUBLIC OF SIGNAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY & VENEZUELA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DWJ and Original Applicant = CINCINNATI SUB-ZERO PRODUCTS, INC.
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