Advanced Sterilization Products: STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

Recall number

Z-2100-2012

Recalling firm

Advanced Sterilization Products

Product

STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

Status

Terminated

Initiated

2012-06-28

Posted

2012-07-27

Terminated

2013-08-13

Reason

Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life.

Root cause

Incorrect or no expiration date

Action

ASP has posted the STERRAD CYCLESURE Biological Indicator customer letter on their external facing website at: wwww.aspjj.com/us/news/cyclesureletter on July 3, 2012. The letter informed customers who purchased STERRAD CYCLESURE 24 Biological Indicator (BI) product that Advanced Sterilization Products (ASP) is recalling certain lots because ASP has determined that it does not have adequate data to support the entire duration of the product's labeled shelf-life. The letter also provided the customers with what actions are needed for the recall. Customers were instructed to return all unused STERRAD CYCLESURE 24 BI product that exceeds the newly determined expiration dated using the enclosed prepaid UPS return label to Stericycle, 2670 Executive Drive Suite A, Indiapolis, IN 46241. Customers were instructed to count their inventory of product that exceeds the newly determined expiration date and record the data on the enclosed Business Reply Card and packing slip that are included with the customer recall letter. Customers were instructed to complete the requested information on the enclosed postage paid Business Reply Card and return it to Stericycle. Customers were instructed to contact Stericycle at (877) 907-7030 if they need additional packing labels. If customers further distribute the affected products to other locations, then they were instructed to contact Stericycle to arrange for return of the product. Customers were instructed that new shipments of STERRAD CYCLESURE 24 BI product will be shipped on July 9, 2012 that has accurate expiration dates that do not require conversion. Customers wil be able to differentiate between current product and the newly shipped product by the lot number. Current product has a lot number containing 6 characters, eg. 123456. Newly shipped product will have a lot number containing 8 characters, eg. 123456EE. Customers with any additional questions were instructed to contact (877) 907-7030 or contact their A

Quantity

38,693 units

Distribution

Worldwide Distribution - USA (nationwide)

Lot, serial or model codes

Lot# 002127, 003127, 005127, 006127, 007127, 008127, 009127, 010127, 011128, 012127, 013127, 014127, 015127, 016127, 018127, 019127, 020127, 021127, 023127, 024127, 025127, 026127, 027127, 028127, 030127, 031127, 032127, 033127, 034127, 035127, 036127, 037127, 038121, 038127 039127, 040127, 041121, 042127, 043127, 044127, 045121, 045127, 046127, 047127, 048127, 049127, 052127, 053121, 053127, 054127, 055121, 056127, 057127, 058127, 059127, 060127, 061127, 062121, 062127, 063127, 064127, 065127, 067127, 068127, 069121, 069127, 070127, 071127, 072127, 073127, 074127, 076121, 077127, 078127, 078128, 079127, 081127, 082127, 084127, 085127, 086121, 086127, 087127, 089127, 090127, 092127, 093121, 094127, 095127, 100121, 100127, 101127, 102127, 104127, 107121, 107127, 107128, 109127, 109128, 110127, 111127, 114121, 114127, 118127, 121121, 121127, 123127, 124127, 125127, 128121, 128127, 129127, 130127, 131127, 132127, 135121, 135127, 136127, 137127, 138127, 139127, 142121, 142127, 143127, 144127, 145127, 146127, 150121, 150127, 151127, 152127, 152128,156127, 157127, 158127, 159127, 160127, 163127, 164127,165127, 339117, 340117, 341117, 342117, 343117, 344117, 345117, 346117, 347117, 348117, 349117, 350117, 351117, 352117, 353117, 354117, 355117, 357117, 360117, 362117, 363117, 364117.

510(k) numbers

["K103222"]

PMA numbers

not on file

Product code

FRC

Firm FEI

3003662624

Firm city

Irvine

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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