Recall Z-0197-2020
Valeritas, Incorporated · initiated July 3, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
Codes / lots: UDI: (01)10385609020015(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM418011 DM418012 DM418013 DM418014 DM418015 DM418016 DM418017 DM418031 DM418033 DM418037
Reason for recall
There is a potential for "No Needle Demo Units" to contain a needle.
FDA-determined cause: Employee error
Action taken
On July 3, 2019, Valeritas issued notices to customers via first class U.S. postal service. The removal strategy is to notify active HCP office accounts from the manufacturing start date of effected product (January 2018) who may have No Needle Demo units in their possession. The removal letter instructs HCP offices to dispose of any No Needle Demo product on hand and acknowledgement by signing and returning the removal letter as instructed.
Details
- Recall number
- Z-0197-2020
- Initiated
- July 3, 2019
- Terminated
- June 24, 2020
- Product code
- LZG – Pump, Infusion, Insulin
- Quantity
- 21,714 devices
- Distribution
- Nationwide within U.S.
- Recalling firm
- Valeritas, Incorporated, Marlborough, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0195-2020 Class II | DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03There is a potential for "No Needle Demo Units" to contain a needle. | 07/03/2019Terminated |
| Z-0196-2020 Class II | DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02There is a potential for "No Needle Demo Units" to contain a needle. | 07/03/2019Terminated |
| Z-0198-2020 Class II | DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03There is a potential for "No Needle Demo Units" to contain a needle. | 07/03/2019Terminated |
| Z-0199-2020 Class II | DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02There is a potential for "No Needle Demo Units" to contain a needle. | 07/03/2019Terminated |