FDAFDA · Food and drugs·Recall number Z-1868-2013
Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Published August 7, 2013 · Recall initiated: June 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mesa Laboratories, Inc., Bozeman Manufacturing Facility
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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