Recall Z-1867-2013— Mesa Laboratories, Inc., Bozeman Manufacturing Facility

Name: FDA recall Z-1867-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-04

Class II · Terminated

Class II FDA medical device recall by Mesa Laboratories, Inc., Bozeman Manufacturing Facility, initiated 2013-06-04, terminated 2013-11-22. It names 2 FDA 510(k) clearances: K963841, K930682. Product: Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.. Reason: 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..

Recalling firm: Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Classification: Class II
Status: Terminated
Initiated: 2013-06-04
Terminated: 2013-11-22
Firm location: Bozeman, MT, United States

510(k) clearances named in this recall

2 on FDA's record

K963841 — EZTESTSgm Biotech, Inc.·cleared 1997-02-25
K930682 — EZTEST-STEAMSgm Biotech, Inc.·cleared 1994-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.