FDA recall Z-1275-2021
Sirtex Medical Limited · Class II · device
Product
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Reason for recall
There is a potential presence of particulate matter in the D-Vial.
Distribution
US Nationwide distribution.
Key facts
- Status
- Terminated
- Initiation date
- 2021-02-22
- Report date
- 2021-03-24
- Termination date
- 2023-04-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- North Ryde, New South Wales, N/A, Australia
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1275-2021