SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For
FDA device recall Z-0028-05 · posted 2004-10-21 · Terminated
Recall details
- Recalling firm
- Ciba Vision Corporation
- Reason for recall
- Stability tests at 24 months revealed failing results for disinfection efficacy.
- Action taken
- Consignees were notified by letter on 10/01/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPN
- Quantity affected
- 5,913,120 units
- Distribution
- Nationwide, Canada, Latin America, Europe, Thailand, South Africa and Asia.
- Date initiated
- 2004-09-27
- Date posted
- 2004-10-21
- Date terminated
- 2005-08-22
- Location
- Duluth, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLO-CARE PLUS MULTIPURPOSE SOLUTION (K031522) | Ciba Vision Corporation | 2003-06-27 |