Class 2 Device Recall EZTest, Ensure, ETIGAM BrightCheq, ParaSure, ConFirm 24 & 10, BT Sure, Assure Accufast, Valisafe

• Date Initiated by Firm: June 04, 2013
• Date Posted: August 01, 2013
• Recall Status: Terminated on November 22, 2013
• Recall Number: Z-1867-2013
• Recall Event ID: 65544
• 510(K)Number: K930682 K963841
• Product Classification: Indicator, biological sterilization process - Product Code FRC
• Product: Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
• Code Information: Lot No S-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21; Lot No S-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15 ; Lot No S-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18.
• Recalling Firm/ Manufacturer: Mesa Laboratories, Inc., Bozeman Manufacturing Facility; 10 Evergreen Dr Ste E; Bozeman MT 59715-2457
• For Additional Information Contact: Glenn Adriance; 303-987-8000 Ext. 10104
• Manufacturer Reason for Recall: Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Mesa Labs sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions contact Mesa Labs at BI-Support@mesalabs.com.
• Quantity in Commerce: 865/25 ct boxes, 414/100 ct boxes, 307/500 ct boxes
• Distribution: Worldwide Distribution: US (nationwide) and countries of: Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Egypt, Greece, India,Israel, Japan, Jordan, Malaysia, Mexico, Milanese, Netherlands, Peru, Portugal, Pozan, Romania, Spain, Sweden, Taiwan, Thailand, United Kingdom, and Uruguay.
• 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 = FRC