Device recall

Z-2261-2014: Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern…

FDA device recall · Class II · Angiodynamics, Inc.

Key facts

Recall number (Z-number) Z-2261-2014
Recall event 68980
Product Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
Product code KRA
Recalling firm Angiodynamics, Inc.
Recall class Class II
Status Terminated
Termination date Mar 27, 2017
510(k) numbers K905447
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

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