Recall Z-0197-2020 ยท LZG Pump, Infusion, Insulin
Valeritas, Incorporated
DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
| Date | Jul 3, 2019 |
| Status | Terminated |
| Reason | There is a potential for "No Needle Demo Units" to contain a needle. |
| Root cause | Employee error |
| Action | On July 3, 2019, Valeritas issued notices to customers via first class U.S. postal service. The removal strategy is to notify active HCP office accounts from the manufacturing start date of effected product (January 2018) who may have No Needle Demo units in their possession. The removal letter instructs HCP offices to dispose of any No Needle Demo product on hand and acknowledgement by signing and returning the removal letter as instructed. |
| Quantity | 21,714 devices |
| Distribution | Nationwide within U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103825 | V-GO INSULIN DELIVERY SYSTEM Valeritas, Inc., Feb 23, 2011 |