Class 2 Device Recall WARM AIR WARMING UNIT

• Date Initiated by Firm: November 14, 2009
• Date Posted: February 04, 2010
• Recall Status: Terminated on January 25, 2012
• Recall Number: Z-0781-2010
• Recall Event ID: 53947
• 510(K)Number: K942599
• Product Classification: System, thermal regulating - Product Code DWJ
• Product: FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming).
• Code Information: Product # 82542; Catalog # 542; Lot #: 07279, 07280, 07424 & 08813.
• Recalling Firm/ Manufacturer: Cincinnati Sub-Zero Products Inc; 12011 Mosteller Rd; Cincinnati OH 45241-1528
• For Additional Information Contact: Kristine Gilkey; 513-772-8810
• Manufacturer Reason for Recall: Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured.
• FDA Determined Cause: Other
• Action: On November 14, 2009, Cincinnati Sub-zero Products, Inc. (CSZ) sent a recall notification letter and response letter to customers. A second notice dated December 10, 2009 was also issued to customers. Customers were instructed in the notifications to assume the recalled product is not sterile and do not use. CSZ requested all affected product be returned to their firm for replacement. Customers are to complete and return the response letter acknowledging receipt of the recall letter. Direct questions to CSZ by calling Customer Service at 1-800- 989-7373. Customers may also call 1-800-989-7373, extension 3234 or 1-51 3-71 9-3234 for recall instructions. Representatives will be available to take your call from 8:30 a.m. until 4:30 p.m. eastern standard time, Monday through Friday.
• Quantity in Commerce: 1,095 Blankets
• Distribution: Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.
• 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