Conformer - Medium (Sterile)
FDA device recall Z-0535-03 · posted 2003-02-05 · Terminated
Recall details
- Recalling firm
- Gulden Ophthalmics
- Reason for recall
- lack of sterility assurance
- Action taken
- The recalling firm issued letters to the accounts requesting the return of the devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- HQX
- Distribution
- Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand
- Date initiated
- 2002-11-29
- Date posted
- 2003-02-05
- Date terminated
- 2004-02-06
- Location
- Elkins Park, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EYE SPHERE, CONFORMERS (K972661) | Gulden Ophthalmics | 1997-10-03 |