Recall Z-2748-2017 ยท FMI Needle, Hypodermic, Single Lumen
Becton Dickinson & Company
BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated
| 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. |
| Root cause | Process control |
| Action | BD sent recall letter/return response form on 9/16/2016. |
| Quantity | 29,500 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951254 | SAFETYGLIDE NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic, Oct 7, 1995 |