Marlborough, MA, United States
Valeritas, Incorporated recalls
1 recall recorded since 2018, most recently on 3 July 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 3 July 2019
- Terminated
- 24 June 2020
- Reason
- There is a potential for "No Needle Demo Units" to contain a needle.
- Distribution
- Nationwide within U.S.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0195-2020, Z-0199-2020, Z-0197-2020, Z-0198-2020, Z-0196-2020
- DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03
- DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02
- DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
- DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03
- DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.