Date Initiated by Firm | August 26, 2009 |
Date Posted | September 16, 2009 |
Recall Status1 |
Terminated 3 on March 08, 2010 |
Recall Number | Z-2212-2009 |
Recall Event ID |
53135 |
510(K)Number | K010724 |
Product Classification |
Lamp, surgical - Product Code FTD
|
Product | Drager Surgical Lights Sola 500 and Sola 700. |
Code Information |
All product with Catalog Number: 4115571. |
Recalling Firm/ Manufacturer |
Draeger Medical, Inc. 3135 Quarry Rd Telford PA 18969-1042
|
For Additional Information Contact | Michael Kelhart 800-543-5047 |
Manufacturer Reason for Recall | welded seam may fail |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Draeger Medical, Inc. issued a "Medical Device Recall" letter dated August 2009 via certified mail with return receipt. Consignees were informed on the affected product and that a service representative will be in contact shortly to schedule a replacement.
For further information, contact Draeger Medical at 1-800-543-5047, press 1 at the prompt and then 2349. |
Quantity in Commerce | 20 units |
Distribution | Nationwide Distribution -- IL, KY, and PA. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = FTD
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