Recall Z-0746-2014— Advanced Sterilization Products

Name: FDA recall Z-0746-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-16

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2013-12-16, terminated 2014-03-27. It names one FDA 510(k) clearance: K023290. Product: STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.. Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems..

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2013-12-16
Terminated: 2014-03-27
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K023290 — STERRAD 50 & STERRAD 100S STERILIZERSAdvanced Sterilization Products·cleared 2003-04-03

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 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

Reason for recall

Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

Data sourced from openFDA. This site is unofficial and independent of the FDA.