Recall Z-0661-2013— Advanced Sterilization Products
Class II · Terminated
Class II FDA medical device recall by Advanced Sterilization Products, initiated 2012-09-20, terminated 2013-10-17. FDA's recall record names no specific 510(k) clearance for this event. Product: STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.. Reason: Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life..
- Recalling firm
- Advanced Sterilization Products
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-20
- Terminated
- 2013-10-17
- Firm location
- Irvine, CA, United States
Product description
STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.
Reason for recall
Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
Data sourced from openFDA. This site is unofficial and independent of the FDA.