Z-0066-2010

Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biological Indicator is...

Name: Z-0066-2010 Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biological Indicator is...
Creator: Advanced Sterilization Products
Published: 2009-06-23
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2009-06-23 / Terminated / root cause: design

FDA source

Advanced Sterilization Products began a recall of Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent... on 2009-06-23. The reason FDA records is "Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maximum incubation time". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0066-2010
Status: Terminated
Initiated: 2009-06-23
Posted: 2009-10-20
Terminated: 2011-11-29
Recalling firm: Advanced Sterilization Products
Product: Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cycles.
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maximum incubation time.
Root cause tag: design
FDA root cause: Device Design
Action: An Important Product Labeling Correction - New Instructions for Use dated, June 26, 2009, has been proposed to be sent by the firm for Cyclosure Biological Indicators to consignees. The revised instructions reduce the maximum read time for the indicators to 3 days (72 hours). The letter also states why ASP changed the Instructions. Questions are to be directed to ASP Customer Care Center.
Distribution: Worldwide Distribution.
Product codes and lots: All Lots.

Product code FRC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)