Z-0267-2018Class II

I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges...

Name: Z-0267-2018 I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges...
Creator: C.R. Bard, Inc.
Published: 2016-12-09
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2016-12-09 / Terminated

FDA source

C.R. Bard, Inc. began a recall of I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of... on 2016-12-09. FDA classified it as Class II and gives the reason as "Activity and quantity of seeds sent in shipments were incorrect". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0267-2018
Classification: Class II
Status: Terminated
Initiated: 2016-12-09
Posted: 2017-12-20
Terminated: 2020-04-24
Recalling firm: C.R. Bard Inc
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.
Product code: KXK Source, Brachytherapy, Radionuclide
Reason for recall: Activity and quantity of seeds sent in shipments were incorrect.
FDA root cause: 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.
Product codes and lots: Product Code: 1251QCSCE, Lot No. BBAY0072, BBAY0079, BBAY0090, BBAY0071, BBAY0073.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0267-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0267-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-20

Product code KXK

K043246Class IIBrachysource Brachytherapy Seed ImplantsC.R. Bard, Inc. / cleared 2005-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)