Device product

DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03

Z-0195-2020

July 03, 2019

Class II

Product summary

Firm: Valeritas, Incorporated
Event: Event 83386
Status: Terminated
Classification: Class II
Quantity: 49,074 devices
Official record key: device-enforcement:Z-0195-2020

Official wording

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

Code information: UDI: (01)10385609020039(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM218001 DM218002 DM218003 DM218004 DM218005 DM218006 DM218020 DM218025 DM218034 DM218035 DM218036

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.