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Recall Observatory FDA recall evidence

Device product

DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02

Z-0199-2020

July 03, 2019

Class II

Product summary

Firm
Valeritas, Incorporated
Event
Event 83386
Status
Terminated
Classification
Class II
Quantity
60 devices
Official record key
device-enforcement:Z-0199-2020

Official wording

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

Code information: UDI: (01)10385609021022(17)XXXXXX(10)XXXXXXXX Lot Number: DM318022

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.