Valeritas Recalls DEMO No Needle Corrugated Cartons Due to Potential Needle Presence
Valeritas is recalling 852 DEMO No Needle Corrugated Cartons because they may contain a needle. The units were distributed nationwide in the U.S.
What this means for you
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, fitting the High severity criteria.
Plain-English summary
Valeritas, Incorporated is recalling 852 units of the DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03. 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 specific lot number for the recalled items is DM218024, and they are identified by the UDI (01)10385609021039(17)XXXXXX(10)XXXXXXXX.
Consumers and healthcare providers should check their inventory for this specific part number and lot number. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations to prevent potential injury.
The recalled product
- Product
- DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03
- Manufacturer
- Valeritas, Incorporated
- Category
- Medical Device — Syringe/Needle
- Hazard
- Affected units
- 852
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)10385609021039(17)XXXXXX(10)XXXXXXXX Lot Number: DM218024
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 Needle Risk
FDA (Devices) · 2019-11-06
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