Device recall

Z-0521-2010: Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation…

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

Key facts

Recall number (Z-number) Z-0521-2010
Recall event 53557
Product Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device for Percutaneous Catheters Used to secure catheters in place without the use of sutures, reducing the exposure of sharps and sharp-related accidents.
Product code KGZ
Recalling firm Merit Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Dec 15, 2009
FEI number 1721504

At a glance

  • None 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)