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.
FDA Recall Z-1104-2017 · Posted None
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Recalling FirmMesa Laboratories Inc
Recall StatusTerminated
Product CodeFRC
Date Initiated2016-04-04
Date Terminated2017-01-26
Product Quantity328/ 50-count/ boxes; 16,400 individual units
Reason for Recall
Product resistance has fallen outside of label claim within expiry.
Firm Action
MesaLabs sent an Urgent Notification letter dated April 4. 2016 to customers. Follow-up emails were sent to verify receipt. The letter identified the affected product, problem and actions to be taken. For questions contact MesaLabs technical support team via email at [email protected] or call at 303-987-8000 ext. 10042.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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