Recall Z-1104-2017 ยท FRC Indicator, Biological Sterilization Process
Mesa Laboratories Inc
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.
| Date | Apr 4, 2016 |
| Status | Terminated |
| Reason | Product resistance has fallen outside of label claim within expiry. |
| Root cause | Process control |
| 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 bi-support@mesalabs.com or call at 303-987-8000 ext. 10042. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971432 | PROSPORE Raven Biological Laboratories, Inc., May 20, 1997 |