Recall Z-1480-04 ยท JOJ Indicator, Physical/Chemical Sterilization Process
Advanced Sterilization Products
Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products''
| Date | Sep 21, 2004 (initiated Sep 4, 2003) |
| Status | Terminated |
| Reason | Performance failure complaints. |
| 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 | 15,334 cases |
| Distribution | Nationwide, Europe, Latin America, Australia, Canada, and Asia Pacific. |
| 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 |