Cidexplus Solution Test Strips
FDA device recall Z-0779-05 · posted 2005-04-27 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- CIDEX test strips were found to pass solution below MEC.
- Action taken
- Customers were notified via urgent product recall letter dated March 16, 2005, to return the product for replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOJ
- Quantity affected
- 3422 cases (2 bottles per case)
- Distribution
- Nationwide & Puerto Rice
- Date initiated
- 2005-03-16
- Date posted
- 2005-04-27
- Date terminated
- 2007-03-20
- 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 FOR CIDEX PRODUCTS (K981054) | Albert Browne , Ltd. | 1998-12-07 |