RecallRadar

FDA Device recall Z-0198-2020

DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03

On 2019-11-06 the FDA classified a Class II recall of DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03 by Valeritas, citing there is a potential for "No Needle Demo Units" to contain a needle.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0198-2020
ClassificationClass II
Statusterminated
Initiated2019-07-03
Published2019-11-06
Last updated2026-09-13 11:55 UTC
CompanyValeritas
DistributionUS

Product

DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03

Reason

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

Identifiers

code_infoUDI: (01)10385609021039(17)XXXXXX(10)XXXXXXXX Lot Number: DM218024

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0198-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.