Recall Z-1274-2018 ยท FRC Indicator, Biological Sterilization Process
Mesa Laboratories Bozeman Manufacturing Facility
SporAmpule Biological Indicator Catalog Number SPS5-100
| Date | Feb 12, 2018 |
| Status | Terminated |
| Reason | The concentration of bromocresol purple in the recalled lots does not conform to specification. |
| Root cause | Other |
| Action | Per the Recall Strategy, consignees have been requested to immediately discontinue use and discard according to site procedures. |
| Quantity | 40,000 units |
| Distribution | United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971432 | PROSPORE Raven Biological Laboratories, Inc., May 20, 1997 |