Recall Z-0604-2014— Advanced Sterilization Products

Name: FDA recall Z-0604-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-26

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2013-11-26, terminated 2014-03-05. It names one FDA 510(k) clearance: K103222. Product: STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.. Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator..

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2013-11-26
Terminated: 2014-03-05
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K103222 — STERRAD CYCLESURE BIOLOGICAL INDICATORAdvanced Sterilization Products·cleared 2011-02-25

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 Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

Reason for recall

Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator.

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