Device recall

Z-2623-2016: White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the…

FDA device recall · Class II · Cook Inc.

Key facts

Recall number (Z-number) Z-2623-2016
Recall event 74010
Product White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.
Product code DQY
Recalling firm Cook Inc.
Recall class Class II
Status Terminated
Termination date Aug 4, 2017
510(k) numbers K902905
FEI number 1820334

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)