Device recall

Z-0055-2012: 8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved…

FDA device recall · Class II · Angiodynamics, INC

Key facts

Recall number (Z-number) Z-0055-2012
Recall event 59526
Product 8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure.
Product code DYB
Recalling firm Angiodynamics, INC
Recall class Class II
Status Terminated
Termination date Mar 7, 2012
510(k) numbers K073100
FEI number 3017892510

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)