Recall Z-1867-2013
Mesa Laboratories, Inc., Bozeman Manufacturing Facility · initiated June 4, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Codes / lots: 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.
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 taken
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.
Details
- Recall number
- Z-1867-2013
- Initiated
- June 4, 2013
- Posted by FDA
- August 1, 2013
- Terminated
- November 22, 2013
- Product code
- FRC – Indicator, Biological Sterilization Process
- Quantity
- 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.
- Recalling firm
- Mesa Laboratories, Inc., Bozeman Manufacturing Facility, Bozeman, MT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1868-2013 Class II | Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in…Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out… | 06/04/2013Terminated |