UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501
FDA device recall Z-0444-03 · posted 2003-01-14 · Terminated
Recall details
- Recalling firm
- Safety Syringes Inc
- Reason for recall
- Package integrity not validated. Sterility not assured.
- Action taken
- Firm initiated recall on 9/5/2002. Visits, telephone calls and letters were the tools used to implement the recall. Unused recalled units were retrieved from customers. This recall is complete.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEG
- Quantity affected
- 3300
- Distribution
- Medical offices located in California.
- Date initiated
- 2002-09-05
- Date posted
- 2003-01-14
- Date terminated
- 2003-12-03
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRASAFE DENTAL INJECTION SYSTEM (K013801) | Safety Syringes, Inc. | 2001-12-13 |