Z-0604-2014Class II

STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for...

Name: Z-0604-2014 STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for...
Creator: Advanced Sterilization Products
Published: 2013-11-26
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2013-11-26 / Terminated / root cause: manufacturing process

FDA source

Advanced Sterilization Products began a recall of STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization... on 2013-11-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0604-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-26
Posted: 2013-12-28
Terminated: 2014-03-05
Recalling firm: Advanced Sterilization Products
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.
Product code: FRC Indicator, Biological Sterilization Process
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A customer notification letter was sent to all customers on 11/26/2013 who purchased the STERRAD CYCLESURE Biological Indicator (BI). The letter informs the customer of the problems identified and the actions to be taken. The customer notification letter includes a table with the products on recall which includes the manufacturing dates, lot numbers, expiration dates, and quantity.
Quantity in commerce: 4048 units total (4014 units in US)
Distribution: Worldwide Distribution.
Product codes and lots: Batch/Lot No. 14913706 15013706 15413706 15413106 15513706 15613706 15713706 15913706 16113706 16113106 16213706 16413706 16413806 16613706 16813706 16813806 16913706 17113706 17213706 17513706 17613706 17713706 17813706 17913706 18013706 18313706 18413706 18913706 19013706 19113706 19213706 19313706 19613706 19713706 19813706 19913706 20013706 20113706 20313706 20413706 20613706 20713706 20813706 21113706 21213706 21313706 21413706 21513706 21513806 21713706 21813706 21913706 22013706 22113706 22213706 22413706 22513706 22613706 22713706 22813706 22913706 23113706 23113806 23213706 23313706 23413706 23513706 23813706 23913706 24013706 24113706 24513706 24813106 24913706 25313106 25613106 26113106 26613106 26813106 27313106 27513106 28713106 28913106 29513106 30113106

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0604-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0604-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-28

Product code FRC

K103222Class IISterrad Cyclesure Biological IndicatorAdvanced Sterilization Products / cleared 2011-02-25

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)