North Ryde, New South Wales, N/A, Australia
Sirtex Medical Limited recalls
1 recall recorded since 2018, most recently on 22 February 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 22 February 2021
- Terminated
- 17 April 2023
- Reason
- There is a potential presence of particulate matter in the D-Vial.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1275-2021
- SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.