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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Valeritas, Incorporated: There is a potential for "No Needle Demo Units" to contain a needle.

Agency Publication Date: October 26, 2019
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Affected Products

Product: DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03

UDI: (01)10385609020039(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM218001 DM218002 DM218003 DM218004 DM218005 DM218006 DM218020 DM218025 DM218034 DM218035 DM218036

Lot Numbers:
Numbers
Product: DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02

UDI: (01)10385609020022(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM318007 DM318008 DM318009 DM318010 DM318026

Lot Numbers:
Numbers
Product: DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01

UDI: (01)10385609020015(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM418011 DM418012 DM418013 DM418014 DM418015 DM418016 DM418017 DM418031 DM418033 DM418037

Lot Numbers:
Numbers
Product: DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03

UDI: (01)10385609021039(17)XXXXXX(10)XXXXXXXX Lot Number: DM218024

Lot Numbers:
Number
Product: DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02

UDI: (01)10385609021022(17)XXXXXX(10)XXXXXXXX Lot Number: DM318022

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83386
Status: Resolved
Manufacturer: Valeritas, Incorporated
Manufactured In: United States
Units Affected: 5 products (49,074 devices; 20,532 devices; 21,714 devices; 852 devices; 60 devices)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.