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Recall Observatory FDA recall evidence

Device product

Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.

Z-1868-2013

June 04, 2013

Class II

Product summary

Firm
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Event
Event 65544
Status
Terminated
Classification
Class II
Quantity
2447/100 count boxes
Official record key
device-enforcement:Z-1868-2013

Official wording

Reason: Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.

Field note

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