FDAClass IINovember 6, 2019

DEMO No Needle Corrugated Carton 40 U/D recall

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

Why was DEMO No Needle Corrugated Carton 40 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)10385609020015(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM418011 DM418012 DM418013 DM418014 DM418015 DM418016 DM418017 DM418031 DM418033 DM418037

Product
DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
Recalling firm
Valeritas, Incorporated
Quantity
21,714 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