Device recall

Z-1275-2021: SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for…

FDA device recall · Class II · Sirtex Medical Limited

Key facts

Recall number (Z-number) Z-1275-2021
Recall event 87393
Product SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Product code IWJ
Recalling firm Sirtex Medical Limited
Recall class Class II
Status Terminated
Termination date Apr 17, 2023
FEI number 3003428886

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)