Date Initiated by Firm |
November 09, 2007 |
Date Posted |
January 09, 2008 |
Recall Status1 |
Terminated 3 on October 17, 2012 |
Recall Number |
Z-0320-2008 |
Recall Event ID |
45852 |
Product Classification |
Transilluminator - Product Code HJM
|
Product |
Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries. --- Chiu Technical Corporation, 252 Indian Head Road, Kings Park, NY 11754. |
Code Information |
All Serial Numbers on the market |
Recalling Firm/ Manufacturer |
Chiu Technical Corp 252 Indian Head Road Kings Park NY 11754-4818
|
For Additional Information Contact |
Mr. Bob Kirzl 631-544-0606
|
Manufacturer Reason for Recall |
Device was marketed without a 510(k).
|
FDA Determined Cause 2 |
Process design |
Action |
On 11/09/07, the recalling firm started faxing the Recall Letter and response form to its customers, informing them of the recall of the unapproved device to the user level. |
Quantity in Commerce |
Domestic: 170 units, Foreign: 21 units |
Distribution |
Worldwide: USA, Canada and India |
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.
|