Z-0198-2020 Class II Terminated
FDA device recall Z-0198-2020 was initiated by Valeritas, Incorporated on July 3, 2019 and is designated Class II. Reason for recall: There is a potential for "No Needle Demo Units" to contain a needle. The recall status is terminated (terminated June 24, 2020). Affected quantity: 852 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- July 3, 2019
- Termination Date
- June 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 852 devices
Product Description
DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03
Reason for Recall
There is a potential for "No Needle Demo Units" to contain a needle.
Distribution Pattern
Nationwide within U.S.
Code Information
UDI: (01)10385609021039(17)XXXXXX(10)XXXXXXXX Lot Number: DM218024