Valeritas Recalls DEMO No Needle Corrugated Cartons Due to Needle Risk
Valeritas is recalling 21,714 DEMO No Needle Corrugated Cartons because they may contain a needle. The recall covers units distributed nationwide in the U.S.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential needle injury) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Valeritas, Incorporated is recalling 21,714 units of the DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01. The recall is being conducted because there is a potential for these "No Needle Demo Units" to contain a needle.
The affected devices were distributed nationwide within the United States. The recall includes specific lot numbers: DM418011, DM418012, DM418013, DM418014, DM418015, DM418016, DM418017, DM418031, DM418033, and DM418037. The UDI for the product is (01)10385609020015(17)XXXXXX(10)XXXXXXXX.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices if they match the recalled description.
The recalled product
- Product
- DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
- Manufacturer
- Valeritas, Incorporated
- Hazard
- Affected units
- 21,714
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Valeritas, Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Valeritas, Incorporated
See all →- HighValeritas Recalls DEMO No Needle Corrugated Cartons Due to Potential Needle Presence
FDA (Devices) · 2019-11-06
- HighValeritas Recalls DEMO No Needle Corrugated Cartons Due to Potential Needle Presence
FDA (Devices) · 2019-11-06
- HighValeritas Recalls DEMO No Needle Corrugated Cartons Due to Potential Needle Presence
FDA (Devices) · 2019-11-06
- HighValeritas Recalls DEMO No Needle Corrugated Cartons Due to Potential Needle Presence
FDA (Devices) · 2019-11-06
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