FDA Device recall Z-0197-2020
DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
- FDA Device
- Class II
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01 by Valeritas, citing there is a potential for "No Needle Demo Units" to contain a needle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0197-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-03 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Valeritas |
| Distribution | US |
Product
DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
Reason
There is a potential for "No Needle Demo Units" to contain a needle.
Identifiers
| code_info | UDI: (01)10385609020015(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM418011 DM418012 DM418013 DM418014 DM418015 DM41…UDI: (01)10385609020015(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM418011 DM418012 DM418013 DM418014 DM418015 DM418016 DM418017 DM418031 DM418033 DM418037 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0197-2020%22
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