Reported Feb 1, 2017 · Terminated

ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog…

Mesa Laboratories Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mesa Laboratories Inc · PO Box 27261 · Omaha, NE · 68127-3623

Is this the product you have?

  • ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus
  • Catalog Number
    • PS-6-50
    • contains 50 Ampoules/Box
  • Product UsageBiological 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
Lot codes and dates
    • Lot # 637
    • exp. date 12/2016
Amount recalled
328/ 50-count/ boxes; 16,400 individual units

Where it was sold

Why it was recalled

Product resistance has fallen outside of label claim within expiry.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 26, 2017 · Data as of Sep 19, 5:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.