FDA Enforcement
Class II
Terminated
DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02
Recall: Z-0199-2020
·
Reported November 6, 2019
Enforcement
- Recall Number
- Z-0199-2020
- Event ID
- 83386
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Valeritas, Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 6, 2019
- Initiation Date
- July 3, 2019
- Classification Date
- October 26, 2019
- Termination Date
- June 24, 2020
- Address
- 293 Boston Post Rd W Ste 330, Marlborough, MA, 01752-4615, United States
Description
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.
Code Info
UDI: (01)10385609021022(17)XXXXXX(10)XXXXXXXX Lot Number: DM318022
Distribution
Nationwide within U.S.
Quantity
60 devices