CLASS II Device recall · Reported 6 Nov 2019 · FDA Enforcement Report
DEMO No Needle Corrugated Carton 20 U/D recalled
Valeritas is recalling DEMO No Needle Corrugated Carton 20 U/D, distributed nationwide in the US. The recall was initiated on 3 Jul 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0195-2020
- FDA event ID
- 83386
- Recalling firm
- Valeritas, Marlborough, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jul 2019
- FDA classified
- 26 Oct 2019
- Reported
- 6 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 3 Jul 2019 | Recall initiated by company | |
| 26 Oct 2019 | Classified by FDA | +115 days |
| 6 Nov 2019 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for "No Needle Demo Units" to contain a needle.
Product as listed by the FDA
DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03
Where it was distributed
Nationwide within U.S.
Questions about this recall
Why was it recalled?
There is a potential for "No Needle Demo Units" to contain a needle.
Which lots are affected?
UDI: (01)10385609020039(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM218001 DM218002 DM218003 DM218004 DM218005 DM218006 DM218020 DM218025 DM218034 DM218035 DM218036
Where was it sold?
Nationwide within U.S.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 83386| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DEMO No Needle Corrugated Carton 30 U/D recalled | Valeritas | Other | Nationwide | |
| CLASS II | DEMO No Needle Corrugated Carton 40 U/D recalled | Valeritas | Other | Nationwide | |
| CLASS II | DEMO No Needle Corrugated Carton 20 U/D recalled | Valeritas | Other | Nationwide | |
| CLASS II | DEMO No Needle Corrugated Carton 30 U/D recalled | Valeritas | Other | Nationwide |
More recalls from Valeritas
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DEMO No Needle Corrugated Carton 30 U/D recalled | Valeritas | Other | Nationwide |
| Device | CLASS II | DEMO No Needle Corrugated Carton 20 U/D recalled | Valeritas | Other | Nationwide |
| Device | CLASS II | DEMO No Needle Corrugated Carton 40 U/D recalled | Valeritas | Other | Nationwide |
| Device | CLASS II | DEMO No Needle Corrugated Carton 30 U/D recalled | Valeritas | Other | Nationwide |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |