medical MODERATE Updated 2017-02-01

Mesa Laboratories Inc recalls ProSpore 4 mL Ampoule Biological indicator for steam sterili

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Recalled 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.

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Hazard / Issue

Product resistance has fallen outside of label claim within expiry.

Issued by

FDA

Affected States: AL, AR, CA, FL, IA, MO, NE, NC, NY, OH, WA
Lot/Code Info: Lot # 637, exp. date 12/2016

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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