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
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Product | M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA.
Brachytherapy source. |
Code Information |
OSI A011, OSI A010, and OSI A015. |
Recalling Firm/ Manufacturer |
Source Production & Equipment Inc 113 Teal St St Rose LA 70087-4022
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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 |
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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 = KXK
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