FDA Device

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

Hazard

Test strips which are used for QC of sterilant solution fail prematurely due to ingress of moisture.

What You Should Do

Remedy

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.

Products

Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips.
Brand
Advanced Sterilization Products
UPC
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

Units Affected

22,992 cases (2 bottles per case)