Device product

DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01

Z-0197-2020

July 03, 2019

Class II

Product summary

Firm: Valeritas, Incorporated
Event: Event 83386
Status: Terminated
Classification: Class II
Quantity: 21,714 devices
Official record key: device-enforcement:Z-0197-2020

Official wording

Reason: There is a potential for "No Needle Demo Units" to contain a needle.

Code information: UDI: (01)10385609020015(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM418011 DM418012 DM418013 DM418014 DM418015 DM418016 DM418017 DM418031 DM418033 DM418037

Distribution pattern: Nationwide within U.S.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

There is a potential for "No Needle Demo Units" to contain a needle.