Z-1773-2012

Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological Indicator is...

Name: Z-1773-2012 Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological Indicator is...
Creator: Advanced Sterilization Products
Published: 2012-02-17
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2012-02-17 / Terminated / root cause: manufacturing process

FDA source

Advanced Sterilization Products began a recall of Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent... on 2012-02-17. The reason FDA records is "The recall was initiated by Advanced Sterilization Products because they recently determined that certain lots of raw materials that were rejected during incoming inspection acceptance test were used for the manufacture...". 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-1773-2012
Status: Terminated
Initiated: 2012-02-17
Posted: 2012-06-06
Terminated: 2013-10-17
Recalling firm: Advanced Sterilization Products
Product: Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological Indicator is 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: The recall was initiated by Advanced Sterilization Products because they recently determined that certain lots of raw materials that were rejected during incoming inspection acceptance test were used for the manufacture of a specific lot range of Sterrad Cyclesure 24 Biological Indicator.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Advanced Sterilization Products a Johnson & Johnson company sent an Urgent Product Recall letter dated March 16, 2012, to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to read the "Details on the Affected Devices/Description of the problem" section in the letter. Customers were instructed to immediately identify and set aside all product listed above in a manner that ensures product will not be used. The lot number and the part number are printed on the label placed around the ampoules. Customers were instructed to return any affected product in accordance with the "Product Return Instructions" section of the letter. Customers were instructed to complete the requested information on the enclosed postage paid business reply card and return it to Stericycle even if they do not have the affected products listed on the letter in stock. Customers with questions were instructed to contact Stericycle at (877) 492-4795. For questions regarding this recall call 949-453-6400.
Quantity in commerce: 2,284 cases (137,040 Biological Indicators)
Distribution: Worldwide Distribution - USA (nationwide) and the countries of AR, AU, BE, BR, CA, EC, HK, JP, MX, and PR
Product codes and lots: Lot# 214117, 216117, 217117, 227117, 227118, and 228117.

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