Mesa Laboratories Bozeman Manufacturing Facility recalls ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471

Recall date

February 12, 2018

Source

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

Recall number

Z-1273-2018

FDA classification

Class II

Brand / firm

Mesa Laboratories Bozeman Manufacturing Facility

Sold / distributed

United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan

Why it was recalled

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

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 Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471