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Class 2 Device Recall I125 CE Marked QuickLink Cartridges |
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Date Initiated by Firm |
December 09, 2016 |
Create Date |
December 20, 2017 |
Recall Status1 |
Terminated 3 on April 24, 2020 |
Recall Number |
Z-0267-2018 |
Recall Event ID |
77439 |
510(K)Number |
K043246
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Product Classification |
Source, brachytherapy, radionuclide - Product Code KXK
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Product |
I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges
Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors. |
Code Information |
Product Code: 1251QCSCE, Lot No. BBAY0072, BBAY0079, BBAY0090, BBAY0071, BBAY0073. |
Recalling Firm/ Manufacturer |
C.R. Bard, Inc. 8195 Industrial Blvd NE Covington GA 30014-1497
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For Additional Information Contact |
770-784-6120
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Manufacturer Reason for Recall |
Activity and quantity of seeds sent in shipments were incorrect.
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FDA Determined Cause 2 |
Other |
Action |
Customers were notified via letter on December 9, 2016. In the case of both customers, the hospital utilized the product to complete the scheduled implants. Adjustments were made to the dose plans and the number of seeds implanted. According to C.R. Bard, the physicians would evaluate the risk by taking into account each individual patient's condition, comorbidities, and treatment plans, and would adjust the dose. For further questions, please call (770) 784-6120. |
Quantity in Commerce |
134 seeds |
Distribution |
Belgium & South Africa. |
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 and Original Applicant = C.R. BARD, INC.
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