| Date Initiated by Firm | February 13, 2007 |
|---|
| Date Posted | July 24, 2007 |
|---|
| Recall Status1 |
Terminated 3 on January 06, 2009 |
| Recall Number | Z-1101-2007 |
|---|
| Recall Event ID |
38075 |
| 510(K)Number | K930711 |
|---|
| Product Classification |
Surgical Exam Light - Product Code FTA
|
| Product | Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount) , TS2015M (mobile) , TS2015W (wall mount) , TS2035M (mobile) |
|---|
| Code Information |
Units manufactured between May 15, 2006 through October 1, 2006 |
Recalling Firm/
Manufacturer |
Sunnex Inc.
3 Huron Dr
Natick MA 01760-1314
|
| For Additional Information Contact | Brian Jacobson
508-651-0009 Ext. 231 |
|---|
Manufacturer Reason
for Recall | Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Sunnex notifiied distributors by letter March 9, 2007. Sunnex is providing replacement product to end users |
|---|
| Quantity in Commerce | 30 lamps |
|---|
| 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.
|
| 510(K) Database | 510(K)s with Product Code = FTA
|
|---|
