—#156058

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.

FDA product code: KXK — Source, Brachytherapy, Radionuclide
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K043246
Affected lot / code info: Product Code: 1251QCSCE, Lot No. BBAY0072, BBAY0079, BBAY0090, BBAY0071, BBAY0073.

Why it was recalled

Activity and quantity of seeds sent in shipments were incorrect.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

Distribution pattern: Belgium & South Africa.

Timeline

Recall initiated: 2016-12-09
Terminated: 2020-04-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156058. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.