Z-1480-04

Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products''

Name: Z-1480-04 Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products''
Creator: Advanced Sterilization Products
Published: 2003-09-04
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2003-09-04 / Terminated

FDA source

Advanced Sterilization Products began a recall of Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products'' on 2003-09-04. The reason FDA records is "Performance failure complaints". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1480-04
Status: Terminated
Initiated: 2003-09-04
Posted: 2004-09-21
Terminated: 2005-01-04
Recalling firm: Advanced Sterilization Products
Product: Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products''
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
Reason for recall: Performance failure complaints.
FDA 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 in commerce: 15,334 cases
Distribution: Nationwide, Europe, Latin America, Australia, Canada, and Asia Pacific.
Product codes and lots: 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

Product code JOJ

K922481Class IIBrowne Ga Indicator Use in 2% Activ GlutaraldehydeBoard of Directors, Albert Browne , Ltd. / cleared 1994-06-02

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)