FDA Device recall Z-1275-2021
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use
- FDA Device
- Class II
- terminated
- Published 2021-03-24
On 2021-03-24 the FDA classified a Class II recall of SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use by Sirtex Medical, citing there is a potential presence of particulate matter in the D-Vial.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1275-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-22 |
| Published | 2021-03-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sirtex Medical |
| Distribution | US |
Product
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Reason
There is a potential presence of particulate matter in the D-Vial.
Identifiers
| code_info | Lot Numbers: 1031234, 1031225, 1031227, 1031229 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1275-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.