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Recall Observatory FDA recall evidence

Device product

Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804

Z-2260-2014

August 06, 2014

Class II

Product summary

Firm
Angiodynamics, Inc.
Event
Event 68980
Status
Terminated
Classification
Class II
Quantity
Domestic: 70 units; Foreign: 27 units
Official record key
device-enforcement:Z-2260-2014

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 4731639 (exp. date 31-Mar-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).