Recall Z-0977-03 ยท MPU Source, Chemiluminescent Light
Watson Diagnostics Inc.
Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box.
| Date | Aug 26, 2003 (initiated Aug 7, 2003) |
| Status | Terminated |
| Reason | Lights split, spilling contents when bent to activate. |
| Root cause | Other |
| Action | Users are instructed to cease use and return the product immediately in a letter issued 8/7/2003 return receipt requested. |
| Quantity | 662 boxes |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963391 | SPECULITE Trylon Corp., Dec 12, 1997 |