Valeritas Recalls DEMO No Needle Corrugated Cartons Due to Potential Needle Presence
Valeritas is recalling DEMO No Needle Corrugated Cartons because they may contain a needle. The recall covers 49,074 units distributed nationwide.
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 presence) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Valeritas, Incorporated is recalling DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03. The recall involves 49,074 devices that were distributed nationwide within the U.S.
The recall is being issued because there is a potential for the "No Needle Demo Units" to contain a needle. This defect presents a risk of injury if the unexpected needle is encountered during handling or use.
Consumers and healthcare providers should stop using the affected devices immediately. The affected lot numbers are DM218001, DM218002, DM218003, DM218004, DM218005, DM218006, DM218020, DM218025, DM218034, DM218035, and DM218036. Users should contact Valeritas for instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03
- Manufacturer
- Valeritas, Incorporated
- Category
- Medical Device — Syringe/Needle
- Hazard
- Affected units
- 49,074
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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