FDA Medical Device Recalls (openFDA)
Advanced Sterilization Products: Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products''
- Recall number
- Z-1480-04
- Recalling firm
- Advanced Sterilization Products
- Product
- Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products''
- Status
- Terminated
- Initiated
- 2003-09-04
- Posted
- 2004-09-21
- Terminated
- 2005-01-04
- Reason
- Performance failure complaints.
- Root cause
- Other
- Action
- Firm issued a Safety Alert to inform users to perform a daily Quality Control check of the test strips to ensure that they are working.
- Quantity
- 15,334 cases
- Distribution
- Nationwide, Europe, Latin America, Australia, Canada, and Asia Pacific.
- Lot, serial or model codes
- CIDEX Activated code 2927, lots: 9520, 9656, 9695, 9804, 9896, 10001 CIDEX Activated Code 2920, lots: 9447, 9522, 9621, 9622, 9661, 9662, 96666, 9764, 9897
- 510(k) numbers
- ["K922481"]
- PMA numbers
- not on file
- Product code
- JOJ
- 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