Recall Z-0043-2014— Advanced Sterilization Products

Name: FDA recall Z-0043-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-18

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2013-09-18, terminated 2014-04-11. It names one FDA 510(k) clearance: K030429. Product: 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..

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2013-09-18
Terminated: 2014-04-11
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K030429 — STERRAD 200 STERILIZERAdvanced Sterilization Products·cleared 2003-08-18

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 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 for recall

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.

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