Recall Z-2751-2017 ยท FMF Syringe, Piston
Becton Dickinson & Company
BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
| Date | Sep 16, 2016 |
| Status | Terminated |
| Reason | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required of 10-6. |
| Root cause | Process control |
| Action | BD sent recall letter/return response form on 9/16/2016. |
| Quantity | 648,000 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110771 | BD SINGLE USE, HYPODERMIC SYRINGE Becton, Dickinson and Company, May 13, 2011 |