Device recall

Z-0777-2017: ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F…

FDA device recall · Class II · Angiodynamics, Inc.

Key facts

Recall number (Z-number) Z-0777-2017
Recall event 75420
Product ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO S PG, Item Number H787065970705, Catalog No.REF…
Product code DYB
Recalling firm Angiodynamics, Inc.
Recall class Class II
Status Terminated
Termination date Jun 18, 2018
510(k) numbers K051655
FEI number 1319211

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)