Z-0695-03

Cidex Plus Solution Test Strips

Name: Z-0695-03 Cidex Plus 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 Plus Solution Test Strips on 2003-02-14. The reason FDA records is "Test strips which are used for QC of sterilant solution fail 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-0695-03
Status: Terminated
Initiated: 2003-02-14
Posted: 2003-03-29
Terminated: 2004-09-27
Recalling firm: Advanced Sterilization Products
Product: Cidex Plus Solution Test Strips
Product code: 6885
Reason for recall: Test strips which are used for QC of sterilant solution fail 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: 10,047 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 Plus, product code 2924, lots: 8423 8560 9229 Cidex Plus, Product code 2926, lots: 8312 8658 9120

Product code 6885

K981054Class IIBrowne Ga Indicator for Cidex ProductsAlbert Browne , Ltd. / cleared 1998-12-07

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)