Recall Z-2006-2019 ยท FMI Needle, Hypodermic, Single Lumen
Terumo Medical Corporation
Terumo Needle, 30G x 1/2", Product Code NN3013R
| Date | Feb 8, 2019 |
| Status | Terminated |
| Reason | There is a potential for a loss of package integrity that may compromise the sterility of the product. |
| Root cause | Packaging |
| Action | Urgent Voluntary Medical Device Recall notification letters dated 2/8/19 were sent to customers. |
| Quantity | 81,000 |
| Distribution | The products were distributed to the following US states: FL, IN, KS, KY, MA, MO, NH, NV, PA, SC, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121607 | TERUMO(R) NEEDLE Terumo (Philippines) Corporation, Nov 8, 2012 |