Recall Z-2008-2019 ยท FMI Needle, Hypodermic, Single Lumen
Becton Dickinson & Company
3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
| Date | Feb 1, 2019 |
| Status | Terminated |
| Reason | The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall notification letters dated 2/1/19 were sent to customers. |
| Quantity | 428,800 |
| Distribution | The products were distributed to the following US states: FL, IL, KS, MA, ND, NH, NY, OH, PA, RI, SC, VA, and WI. The products were distributed to the following foreign countries: Suriname. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944757 | PISTON SYRINGES Bd Becton Dickinson Vacutainer Systems Preanalytic, Jan 11, 1995 |