Advanced Sterilization Products

Entity profile compiled from public source records

Public Record Profile Registrations: 2 510(k) filings: 0 Recalls: 2

Known Identifiers & Locations

FEI Numbers 3003662624, 3015392401
Owner Operator Numbers 9068155
Locations Covered Irvine, CA, US; SCHAFFHAUSEN, CH

Registered Establishments (2)

Registration # Establishment Name Location Establishment Type(s) Action
2084725 ADVANCED STERILIZATION PRODUCTS Irvine, CA, US Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details
3015392401 ASP Global Manufacturing GmbH SCHAFFHAUSEN, CH Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (2)

Recall # Product Description Initiation Date Status Action
Z-0043-2014 STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions. 2013-09-18 Terminated View Details
Z-0044-2014 STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Reason: Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life. 2013-09-18 Terminated View Details

Profile Disclaimer

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