| Date Initiated by Firm | March 03, 2008 |
|---|
| Create Date | June 25, 2015 |
|---|
| Recall Status1 |
Terminated 3 on August 19, 2009 |
| Recall Number | Z-1717-2009 |
|---|
| Recall Event ID |
52428 |
| 510(K)Number | K052947 |
|---|
| Product Classification |
Source, brachytherapy, radionuclide - Product Code KXK
|
| Product | M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA.
Brachytherapy source. |
|---|
| Code Information |
OSI A011, OSI A010, and OSI A015. |
| FEI Number |
1000437833
|
Recalling Firm/
Manufacturer |
Source Production & Equipment Inc
113 Teal St
St Rose
LA
70087-4022
|
| For Additional Information Contact | Kevin Schehr
504-464-9471 |
|---|
Manufacturer Reason
for Recall | Radioactive source broke during use. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Source Production and Equipment, Inc. notified the Distributor by phone and letter March 2008 and requested the return of all affected units. |
|---|
| Quantity in Commerce | 3 units |
|---|
| Distribution | Nationwide Distribution -- GA, NV and NY. |
|---|
| 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 = KXK
|
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