Z-0116-2007

Venoscope Neonatal Transilluminator, Model NT01

Name: Z-0116-2007 Venoscope Neonatal Transilluminator, Model NT01
Creator: Venoscope LLC
Published: 2005-04-28
License: https://open.fda.gov/license/

Venoscope LLC / initiated 2005-04-28 / Terminated

FDA source

Venoscope LLC began a recall of Venoscope Neonatal Transilluminator, Model NT01 on 2005-04-28. The reason FDA records is "Excessive heating due to incorrect wire assembly process". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0116-2007
Status: Terminated
Initiated: 2005-04-28
Posted: 2006-10-28
Terminated: 2007-02-21
Recalling firm: Venoscope LLC
Product: Venoscope Neonatal Transilluminator, Model NT01
Product code: HJN Transilluminator, Battery-Powered
Reason for recall: Excessive heating due to incorrect wire assembly process.
FDA 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 in commerce: 118 distributed
Distribution: Nationwide
Product codes and lots: 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.

Product code HJN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)