Z-1868-2013 Class II Terminated
FDA device recall Z-1868-2013 was initiated by Mesa Laboratories, Inc., Bozeman Manufacturing Facility on June 4, 2013 and is designated Class II. 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. The recall status is terminated (terminated November 22, 2013). Affected quantity: 2447/100 count boxes.
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2013
- Initiation Date
- June 4, 2013
- Termination Date
- November 22, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2447/100 count boxes
Product Description
Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
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.
Distribution Pattern
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.
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.