Recall Z-0694-03 ยท 688
Advanced Sterilization Products
Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips.
| Date | Mar 29, 2003 (initiated Feb 14, 2003) |
| Status | Terminated |
| Reason | Test strips which are used for QC of sterilant solution fail prematurely due to ingress of moisture. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922481 | BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE Board of Directors, Albert Browne , Ltd., Jun 2, 1994 |