FDAClass IINovember 6, 2019

DEMO No Needle Corrugated Carton 20 U/D recall

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

Why was DEMO No Needle Corrugated Carton 20 U/D recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03
Recalling firm
Valeritas, Incorporated
Quantity
49,074 devices
Distribution
Nationwide within U.S.
Recall date
November 6, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls