FDA recall Z-0267-2018

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.

Reason for recall

Activity and quantity of seeds sent in shipments were incorrect.

Distribution

Belgium & South Africa.

Key facts

Status

Terminated

Initiation date

2016-12-09

Report date

2017-12-27

Termination date

2020-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0267-2018