Recall Z-1180-2013— Advanced Sterilization Products
Class II · Terminated
Class II FDA medical device recall by Advanced Sterilization Products, initiated 2013-04-22, terminated 2013-08-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- Advanced Sterilization Products
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-22
- Terminated
- 2013-08-01
- Firm location
- Irvine, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.