Device recall

Z-0875-2022: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN…

FDA device recall · Class III · Cook Medical Incorporated

Key facts

Recall number (Z-number) Z-0875-2022
Recall event 89689
Product Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918
Product code DTK
Recalling firm Cook Medical Incorporated
Recall class Class III
Status Terminated
Termination date Nov 7, 2024
510(k) numbers K211874
FEI number 3005580113

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 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

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