Recall Z-0199-2020— Valeritas, Incorporated

Name: FDA recall Z-0199-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-03

Class II · Terminated

Class II FDA medical device recall by Valeritas, Incorporated, initiated 2019-07-03, terminated 2020-06-24. It names one FDA 510(k) clearance: K103825. Product: DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02. Reason: There is a potential for "No Needle Demo Units" to contain a needle..

Recalling firm: Valeritas, Incorporated
Classification: Class II
Status: Terminated
Initiated: 2019-07-03
Terminated: 2020-06-24
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K103825 — V-GO INSULIN DELIVERY SYSTEMValeritas, Inc.·cleared 2011-02-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.