Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products''
FDA device recall Z-1480-04 · posted 2004-09-21 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- Performance failure complaints.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOJ
- Quantity affected
- 15,334 cases
- Distribution
- Nationwide, Europe, Latin America, Australia, Canada, and Asia Pacific.
- Date initiated
- 2003-09-04
- Date posted
- 2004-09-21
- Date terminated
- 2005-01-04
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE (K922481) | Board of Directors, Albert Browne , Ltd. | 1994-06-02 |