Class 2 Device Recall SteriProbe Temperature Probe

• Date Initiated by Firm: September 26, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated on August 13, 2013
• Recall Number: Z-0372-2012
• Recall Event ID: 60307
• 510(K)Number: K072621
• Product Classification: temperature probe - Product Code BZT
• Product: Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622, Catalog #491B. TA disposable temperature probe used in conjunction with a measuring/monitoring device to continuously measure/monitor a patient's core body temperature.
• Code Information: The following lot codes are subject to recall: 12998, 12999, 19257, 19257A, 19644, 21536, 21537, 27446, 29112, 31081, 31082, 32209, 37281, 38522, 8996, D414723, D416607, D420120, D421702, D423801, D423908, D525212, D515408, D516607, D517108, D520709, D524107, D525502, D527632, D530518, D624011, D624012, D634834; ; D706611, D709119, D720450, D721118, D722015, and D727416.
• FEI Number: 1516825
• Recalling Firm/ Manufacturer: Cincinnati Sub-Zero Products Inc; 12011 Mosteller Rd; Cincinnati OH 45241
• For Additional Information Contact: Beatrice Washington; 513-772-8810
• Manufacturer Reason for Recall: Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Cincinnati Sub-Zero Products, Inc., issued an "Urgent Medical Device Field Action" letter on November 1, 2011 to all affected customers. The letter includes; description of product and problem, and a list of the affected lot numbers. The letter instructs the customers to discontinue use of the device. All unused product is to be returned to the Biomedical/Clinical Engineering and/or Service Department for an replacement and all used probes are to be disposed of in accordance with hospital policy. The customers are also instructed to complete and return an attached Recall Response Form ASAP. For additional information, customers may contact the Beatrice Washington at 1-800-989-7373 or (513) 772-8810.
• Quantity in Commerce: 369,680
• Distribution: Nationwide distribution and Canada.
• 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 = BZT