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U.S. Department of Health and Human Services

Class 2 Device Recall Mesa Labs, ETIGAM BrightCheq, and Getinge Assure Accufast

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  Class 2 Device Recall Mesa Labs, ETIGAM BrightCheq, and Getinge Assure Accufast see related information
Date Initiated by Firm June 04, 2013
Date Posted August 01, 2013
Recall Status1 Terminated 3 on November 22, 2013
Recall Number Z-1868-2013
Recall Event ID 65544
510(K)Number K093794  K112081  
Product Classification Indicator, biological sterilization process - Product Code FRC
Product Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM.

Intended for use in determining the efficacy of steam sterilization processes.
Code Information Lot No SR-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21;  Lot No SR-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15.  Lot No SR-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		 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 2		 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 2447/100 count 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 and Original Applicant = SGM BIOTECH, INC.
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