Class 2 Device Recall AMSCO WARMING CABINET

• Date Initiated by Firm: November 20, 2015
• Create Date: January 06, 2016
• Recall Status: Terminated on October 27, 2016
• Recall Number: Z-0603-2016
• Recall Event ID: 72825
• 510(K)Number: K111870
• Product Classification: Warmer, thermal, infusion fluid - Product Code LGZ
• Product: AMSCO Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
• Code Information: Serial #'s: 0428014026 - 0432115014
• Recalling Firm/ Manufacturer: Steris Corporation; 5960 Heisley Rd; Mentor OH 44060-1834
• For Additional Information Contact: Ms. Kathryn E. Cadorette; 440-392-7231
• Manufacturer Reason for Recall: The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature.
• FDA Determined Cause: Process change control
• Action: The firm, Steris, sent an "URGENT VOLUNTARY FIELD CORRECTION NOTICE" letter dated 12/14/2015 to its customers. The letter described the product, problem and actions to be taken. The firm included an updated quick reference magnet for each affected unit with the letter. The customers were instructed to replace your existing magnet with the enclosed magnet. If you have questions regarding this matter, please contact Product Manager, at 440-392-7705 or STERIS Customer Service at 1-800-548-4873.
• Quantity in Commerce: 2,319 units
• Distribution: Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Bahrain, Canada, China, Colombia, Costa Rica, France, Hong Kong, India, Indonesia, Israel, Kuwait, Lebanon, Mexico, Panama, Peru, Republic of Korea, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, Viet Nam & Virgin Islands.
• 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 = LGZ