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U.S. Department of Health and Human Services

Class 2 Device Recall WARM AIR WARMING UNIT

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 Class 2 Recall
WARM AIR WARMING UNIT
see related information
Date Posted February 04, 2010
Recall Status1 Terminated on January 25, 2012
Recall Number Z-0781-2010
Recall Event ID 53947
Premarket Notification
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, Ohio 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 2
OTHER/UNDETERMINED: Pending
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 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 = CINCINNATI SUB-ZERO PRODUCTS, INC.
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