Recall Z-2174-2013— Advanced Sterilization Products

Name: FDA recall Z-2174-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-25

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2013-07-25, terminated 2013-11-27. It names one FDA 510(k) clearance: K071385. Product: STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.. Reason: The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life..

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2013-07-25
Terminated: 2013-11-27
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K071385 — STERRAD 100NX STERILIZERAdvanced Sterilization Products·cleared 2007-11-29

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 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

Reason for recall

The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life.

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