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/ Manufacturer |
Venoscope LLC 1018 Harding Street Suite 104 Lafayette LA 70503
|
For Additional Information Contact |
Frank Creaghan 800-294-7655
|
Manufacturer Reason for Recall |
Excessive heating due to incorrect wire assembly process.
|
FDA Determined Cause 2 |
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
|
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.
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