FDA recall Z-0197-2020
Valeritas, Incorporated · Class II · device
Product
DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
Reason for recall
There is a potential for "No Needle Demo Units" to contain a needle.
Distribution
Nationwide within U.S.
Key facts
- Status
- Terminated
- Initiation date
- 2019-07-03
- Report date
- 2019-11-06
- Termination date
- 2020-06-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Marlborough, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0197-2020