Recall Z-1104-2017— Mesa Laboratories Inc

Name: FDA recall Z-1104-2017
Creator: U.S. Food and Drug Administration
Published: 2016-04-04

Class II · Terminated

Class II FDA medical device recall by Mesa Laboratories Inc, initiated 2016-04-04, terminated 2017-01-26. It names one FDA 510(k) clearance: K971432. Product: ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.. Reason: Product resistance has fallen outside of label claim within expiry..

Recalling firm: Mesa Laboratories Inc
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Terminated: 2017-01-26
Firm location: Omaha, NE, 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

ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.

Reason for recall

Product resistance has fallen outside of label claim within expiry.

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