FDA Medical Device Recalls (openFDA)
Valeritas, Incorporated: DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
- Recall number
- Z-0197-2020
- Recalling firm
- Valeritas, Incorporated
- Product
- DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
- Status
- Terminated
- Initiated
- 2019-07-03
- Posted
- not on file
- Terminated
- 2020-06-24
- Reason
- There is a potential for "No Needle Demo Units" to contain a needle.
- Root cause
- Employee error
- Action
- On July 3, 2019, Valeritas issued notices to customers via first class U.S. postal service. The removal strategy is to notify active HCP office accounts from the manufacturing start date of effected product (January 2018) who may have No Needle Demo units in their possession. The removal letter instructs HCP offices to dispose of any No Needle Demo product on hand and acknowledgement by signing and returning the removal letter as instructed.
- Quantity
- 21,714 devices
- Distribution
- Nationwide within U.S.
- Lot, serial or model codes
- UDI: (01)10385609020015(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM418011 DM418012 DM418013 DM418014 DM418015 DM418016 DM418017 DM418031 DM418033 DM418037
- 510(k) numbers
- ["K103825"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3003154078
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28