Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box.
FDA device recall Z-0977-03 · posted 2003-08-26 · Terminated
Recall details
- Recalling firm
- Watson Diagnostics Inc.
- Reason for recall
- Lights split, spilling contents when bent to activate.
- Action taken
- Users are instructed to cease use and return the product immediately in a letter issued 8/7/2003 return receipt requested.
- Root cause
- Other
- Status
- Terminated
- Product code
- MPU
- Quantity affected
- 662 boxes
- Distribution
- Nationwide.
- Date initiated
- 2003-08-07
- Date posted
- 2003-08-26
- Date terminated
- 2007-12-14
- Location
- Corona, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECULITE (K963391) | Trylon Corp. | 1997-12-12 |