# FDA recall Z-1702-2018

> **Bard Brachytherapy, Inc.** · Class II · device recall initiated 2018-04-10.

## 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.

## 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.

## Distribution

US Distribution to the states of : California and Georgia

## Key facts

- **Recall number:** Z-1702-2018
- **Recalling firm:** Bard Brachytherapy, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-10
- **Report date:** 2018-05-16
- **Termination date:** 2020-06-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carol Stream, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1702-2018

## Citation

> AI Analytics. FDA recall Z-1702-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1702-2018. Source: US FDA. Licensed CC0.

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