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.
Recall
- Recall Number
- Z-1104-2017
- Event Number
- 76101
- Firm
- Mesa Laboratories Inc
- FEI Number
- 3013667284
- Product Code
- FRC
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 4, 2016
- Terminated
- January 26, 2017
- Address
- 8607 Park Dr PO Box 27261, Omaha, NE, 68127-3623
Description
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.
Product resistance has fallen outside of label claim within expiry.
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.
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.
328/ 50-count/ boxes; 16,400 individual units