Skip to content
Recall Observatory FDA recall evidence

Device product

Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804

Z-2262-2014

August 06, 2014

Class II

Product summary

Firm
Angiodynamics, Inc.
Event
Event 68980
Status
Terminated
Classification
Class II
Quantity
Domestic: 36 units
Official record key
device-enforcement:Z-2262-2014

Official wording

Reason: AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).

Code information: Lot 4762513 (exp. date 31-May-17)

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).