Recall Z-0843-2015— Advanced Sterilization Products

Name: FDA recall Z-0843-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-04

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2014-11-04, terminated 2015-08-04. It names one FDA 510(k) clearance: K023290. Product: STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.. Reason: Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide..

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2014-11-04
Terminated: 2015-08-04
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, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

Reason for recall

Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.

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