Device recall

Z-1842-2022: Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN…

FDA device recall · Class II · Cook Incorporated

Key facts

Recall number (Z-number) Z-1842-2022
Recall event 90793
Product Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
Product code DQX
Recalling firm Cook Incorporated
Recall class Class II
Status Open, Classified
510(k) numbers K171764
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)