Device recall

Z-0558-2011: Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Manufactured by Merit…

FDA device recall · Class II · Merit Medical Systems, Inc.

Key facts

Recall number (Z-number) Z-0558-2011
Recall event 57176
Product Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Manufactured by Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,
Product code DQO
Recalling firm Merit Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Mar 23, 2012
510(k) numbers K913682
FEI number 1721504

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)