Recall Z-1773-2012 ยท FRC Indicator, Biological Sterilization Process
Advanced Sterilization Products
Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
| Date | Jun 6, 2012 (initiated Feb 17, 2012) |
| Status | Terminated |
| Reason | The recall was initiated by Advanced Sterilization Products because they recently determined that certain lots of raw materials that were rejected during incoming inspection acceptance test were used for the manufacture of a specific lot range of Sterrad Cyclesure 24 Biological Indicator. |
| Root cause | Process control |
| Action | Advanced Sterilization Products a Johnson & Johnson company sent an Urgent Product Recall letter dated March 16, 2012, to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to read the "Details on the Affected Devices/Description of the problem" section in the letter. Customers were instructed to immediately identify and set aside all product listed above in a manner that ensures product will not be used. The lot number and the part number are printed on the label placed around the |
| Quantity | 2,284 cases (137,040 Biological Indicators) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of AR, AU, BE, BR, CA, EC, HK, JP, MX, and PR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103222 | STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products, Feb 25, 2011 |