Z-1702-2018Class II

BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125...

Name: Z-1702-2018 BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125...
Creator: Bard Brachytherapy, Inc.
Published: 2018-04-10
License: https://open.fda.gov/license/

Bard Brachytherapy, Inc. / initiated 2018-04-10 / Terminated / root cause: labeling and UDI

FDA source

Bard Brachytherapy, Inc. began a recall of BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored... on 2018-04-10. FDA classified it as Class II and gives the reason as "Bard Medical Division is recalling the BARD BrachySource Iodine125 Radioactive Seeds in Mick Applicators and BARD BrachySource Iodine125 Radioactive Seeds Loose in Vial with Sterile Spacers. Because the incorrect dosage...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1702-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-10
Posted: 2018-04-27
Terminated: 2020-06-05
Recalling firm: Bard Brachytherapy, Inc.
Product: BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource Seed Implants absorbs the electrons.
Product code: KXK Source, Brachytherapy, Radionuclide
Reason for recall: Bard Medical Division is recalling the BARD BrachySource Iodine125 Radioactive Seeds in Mick Applicators and BARD BrachySource Iodine125 Radioactive Seeds Loose in Vial with Sterile Spacers. Because the incorrect dosage level radioactive seeds were mixed up and sent to two hospitals. One Hospital ordered BrachySource Iodine125 0.36 mCi radioactive seeds but instead received BrachySource Iodine125 0.28 mCi radioactive seeds and vice versa for the other hospital affected.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The notification to the customer was completed by Bard Medical Customer Service via a telephone call to alert them of the incorrect product shipped on April 10, 2018. Bard Medical Division is recalling the BARD BrachySource Iodine125 Radioactive Seeds in Mick Applicators and BARD BrachySource Iodine125 Radioactive Seeds Loose in Vial with Sterile Spacers. The incorrect dosage level of radioactive seeds was sent to 2 hospitals. One hospital ordered 0.36 mCi radioactive seeds but instead received 0.28 mCi radioactive seeds intended for the other hospital. For further questions, please call (770) 385-0562.
Quantity in commerce: 70 Seeds at 0.28mCi and 100 seeds at 0.36mCi
Distribution: US Distribution to the states of : California and Georgia
Product codes and lots: Product Code:1251CSR, BrachySource¿ Seed Implants in Re-Usable Mick¿ Applicators (60 seeds at 0.28mCi) with Lot BBCP0079 Product Code: 1251CSRA, BrachySource¿ Seed Implants in Shielded Mick¿ Applicators (10 seeds at 0.28mCi) with Lot BBCQ0026 Product Code: PS1251LS, Loose BrachySource¿ Seed Implants (with Lot BBCQ0050) Spacers (with Lot 23498276) 100 Seeds at 0.36 mCi.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1702-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1702-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-07

Product code KXK

K093663Class IIRadionuclide Brachytherapy SourceC.R. Bard, Inc. / cleared 2009-12-23

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)