Recall Z-1197-2017— Advanced Sterilization Products
Class II · Terminated
Class II FDA medical device recall by Advanced Sterilization Products, initiated 2017-01-09, terminated 2017-11-02. It names 3 FDA 510(k) clearances: K151725, K142454, K042116. Product: STERRAD NX Sterilization System, Product Code: 10033, 10033-002. Reason: Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration..
- Recalling firm
- Advanced Sterilization Products
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-09
- Terminated
- 2017-11-02
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K151725 — STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
- K142454 — STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
- K042116 — STERRAD NX STERILIZER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Reason for recall
Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.
Data sourced from openFDA. This site is unofficial and independent of the FDA.