Z-0694-03

Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips

Name: Z-0694-03 Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips
Creator: Advanced Sterilization Products
Published: 2003-02-14
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2003-02-14 / Terminated / root cause: sterility

FDA source

Advanced Sterilization Products began a recall of Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips on 2003-02-14. The reason FDA records is "Test strips which are used for QC of sterilant solution fail prematurely due to ingress of moisture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0694-03
Status: Terminated
Initiated: 2003-02-14
Posted: 2003-03-29
Terminated: 2004-09-27
Recalling firm: Advanced Sterilization Products
Product: Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips.
Product code: 6885
Reason for recall: Test strips which are used for QC of sterilant solution fail prematurely due to ingress of moisture.
Root cause tag: sterility
FDA root cause: Other
Action: Several emails and letters were sent between 2/14/03 and 2/27/03 to customers requesting return of product and also advising them that should return not be a viable option due to availability of replacements, a suggested temporary QC procedure could be used to separate good lots of strips from affected lots.
Quantity in commerce: 22,992 cases (2 bottles per case)
Distribution: Nationwide. Australia, Brazil, Canada, Puerto Rico, Colombia, Japan, Korea, South Africa, Thailand, England, Uruguay, Venezuela, Republic of Panama.
Product codes and lots: Cidex Activated, Product Code 2920 lots: 7840 7739 8064 8503 8422 8661 8771 8923 9188 9313 9414 Cidex Plus, Product Code 2924, lots: Cidex Activated, Product code 2927, lots: 7783 8160 8182 8604 8790 9317 9404

Product code 6885

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)