FDA recall Z-2327-2021

Product

TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

Reason for recall

Potential for leaks and loosening at the patient catheter connection

Distribution

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.

Key facts

Status

Ongoing

Initiation date

2021-07-23

Report date

2021-08-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2327-2021