Recall Z-0444-03 ยท MEG Syringe, Antistick
Safety Syringes Inc
UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501
| Date | Jan 14, 2003 (initiated Sep 5, 2002) |
| Status | Terminated |
| Reason | Package integrity not validated. Sterility not assured. |
| Root cause | Other |
| Action | 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. |
| Quantity | 3300 |
| Distribution | Medical offices located in California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013801 | ULTRASAFE DENTAL INJECTION SYSTEM Safety Syringes, Inc., Dec 13, 2001 |