Mesa Laboratories Inc recalls ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Nu…

Recall date

April 4, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1104-2017

FDA classification

Class II

Brand / firm

Mesa Laboratories Inc

Sold / distributed

Product was distributed to: AL, AR, CA, FL, IA, MO, NE, NC, NY, OH, and WA. The product was also distributed internationally, including Mexico and Canada. There was no goverment or military distribution.

Why it was recalled

Product resistance has fallen outside of label claim within expiry.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.