Recall Z-1274-2018— Mesa Laboratories Bozeman Manufacturing Facility

Name: FDA recall Z-1274-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-12

Class II · Terminated

Class II FDA medical device recall by Mesa Laboratories Bozeman Manufacturing Facility, initiated 2018-02-12, terminated 2018-07-03. It names one FDA 510(k) clearance: K971432. Product: SporAmpule Biological Indicator Catalog Number SPS5-100. Reason: The concentration of bromocresol purple in the recalled lots does not conform to specification..

Recalling firm: Mesa Laboratories Bozeman Manufacturing Facility
Classification: Class II
Status: Terminated
Initiated: 2018-02-12
Terminated: 2018-07-03
Firm location: Boseman, MT, United States

510(k) clearances named in this recall

1 on FDA's record

K971432 — PROSPORERaven Biological Laboratories, Inc.·cleared 1997-05-20

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

SporAmpule Biological Indicator Catalog Number SPS5-100

Reason for recall

The concentration of bromocresol purple in the recalled lots does not conform to specification.

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