FDA Medical Device Recalls (openFDA)
Advanced Sterilization Products: 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.
- Recall number
- Z-0066-2010
- 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.
- Status
- Terminated
- Initiated
- 2009-06-23
- Posted
- 2009-10-20
- Terminated
- 2011-11-29
- Reason
- 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
- 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.
- Quantity
- not on file
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- All Lots.
- 510(k) numbers
- ["K031226","K994055"]
- PMA numbers
- not on file
- Product code
- FRC
- Firm FEI
- 3003662624
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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