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U.S. Department of Health and Human Services

Class 2 Device Recall Venoscope Neonatal Transilluminator

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  Class 2 Device Recall Venoscope Neonatal Transilluminator see related information
Date Initiated by Firm April 28, 2005
Date Posted October 28, 2006
Recall Status1 Terminated 3 on February 21, 2007
Recall Number Z-0116-2007
Recall Event ID 36548
510(K)Number K951422  
Product Classification Neonatal Transilluminator - Product Code HJN
Product Venoscope Neonatal Transilluminator, Model NT01
Code Information 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.
Recalling Firm/
Venoscope LLC
1018 Harding Street
Suite 104
Lafayette LA 70503
For Additional Information Contact Frank Creaghan
Manufacturer Reason
for Recall
Excessive heating due to incorrect wire assembly process.
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.