FDAClass IIFebruary 1, 2017

ProSpore recall

ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50…

Why was ProSpore recalled?

Product resistance has fallen outside of label claim within expiry.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 637, exp. date 12/2016

Product
ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50…
Recalling firm
Mesa Laboratories Inc
Quantity
328/ 50-count/ boxes; 16,400 individual units
Distribution
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.
Recall date
February 1, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls