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U.S. Department of Health and Human Services

Class 2 Device Recall I125 CE Marked QuickLink Cartridges

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  Class 2 Device Recall I125 CE Marked QuickLink Cartridges see related information
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  
Product Classification Source, brachytherapy, radionuclide - Product Code KXK
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
For Additional Information Contact
770-784-6120
Manufacturer Reason
for Recall		 Activity and quantity of seeds sent in shipments were incorrect.
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
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 and Original Applicant = C.R. BARD, INC.
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