Device recall

Z-0334-2025: CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use…

FDA device recall · Class II · The Metrix Company

Key facts

Recall number (Z-number) Z-0334-2025
Recall event 95499
Product CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Product code KPE
Recalling firm The Metrix Company
Recall class Class II
Status Open, Classified
510(k) numbers K030888
FEI number 1000117446

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)