Recall Z-1180-2013 ยท FRC Indicator, Biological Sterilization Process
Advanced Sterilization Products
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
| Date | Apr 26, 2013 (initiated Apr 22, 2013) |
| Status | Terminated |
| Reason | Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life. |
| Root cause | Under Investigation by firm |
| Action | Advanced Sterilization Products sent an Urgent Medical Device Recall letter dated April 22 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers that have installed and validated STERRAD system between Feb 2012 and March 2013, are instructed to contact Stericycle at (888) 943-4901 to determine if their STERRAD System is eligible for an optional revalidation. If customers would like to have their system validation repeated, ASP will revalidate their system without charge. Customers are instructed that th |
| Quantity | 69,994 cases |
| Distribution | Worldwide Distribution - Nationwide Distribution including the states of AR, AL, AK, AZ, CA, CT, CO, DE, FL, GA, HI, IA, IL, IN, ID, KY, LA, MA, ME, MD, MI, MS, MN, MO, MT, NC, ND, NE, NJ, NY, NV, NH, NM, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV., and the countries of AR, AU, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.