Venoscope Neonatal Transilluminator, Model NT01
FDA Recall Z-0116-2007 · Posted 2006-10-28
Recalling FirmVenoscope LLC
Recall StatusTerminated
Product CodeHJN
Date Initiated2005-04-28
Date Terminated2007-02-21
Product Quantity118 distributed
Reason for Recall
Excessive heating due to incorrect wire assembly process.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.