FDA Medical Device Recalls (openFDA)
Venoscope LLC: Venoscope Neonatal Transilluminator, Model NT01
- Recall number
- Z-0116-2007
- Recalling firm
- Venoscope LLC
- Product
- Venoscope Neonatal Transilluminator, Model NT01
- Status
- Terminated
- Initiated
- 2005-04-28
- Posted
- 2006-10-28
- Terminated
- 2007-02-21
- Reason
- Excessive heating due to incorrect wire assembly process.
- Root cause
- Other
- Action
- The firm notified its consignees about the problem beginning on 04/28/2006 and requested the consignee (nurses and distributors) open the battery compartment and check for the absence of an identifying mark (there are no exterior lot numbers). The recalling firm requested the return of all lights which had no identifying marks inside the battery compartment.
- Quantity
- 118 distributed
- Distribution
- Nationwide
- Lot, serial or model codes
- The product is not lot coded on the exterior of the device and could not be identified by the consignee without disassembling the device to find the lack of an identifying mark.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HJN
- Firm FEI
- 1000306918
- Firm city
- Lafayette
- Firm state
- LA
- 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