Valeritas Recalls DEMO No Needle Corrugated Cartons Due to Potential Needle Presence
Valeritas is recalling 60 DEMO No Needle Corrugated Cartons because they may contain a needle. The units were 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 the hazard is explicitly stated but no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.
Plain-English summary
Valeritas, Incorporated is recalling 60 units of the DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02. The recall is being conducted because there is a potential for these "No Needle Demo Units" to contain a needle.
The affected devices are identified by UDI (01)10385609021022(17)XXXXXX(10)XXXXXXXX and Lot Number DM318022. These products were distributed nationwide within the United States.
Consumers and healthcare providers should stop using these specific demo units immediately and contact Valeritas, Incorporated for further instructions or a return.
The recalled product
- Product
- DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02
- Manufacturer
- Valeritas, Incorporated
- Hazard
- Affected units
- 60
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)10385609021022(17)XXXXXX(10)XXXXXXXX Lot Number: DM318022
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 Needle Risk
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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