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Terminated

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

FDA Recall Z-2262-2014 · Posted 2014-08-18

Recalling FirmAngiodynamics, Inc.
Recall StatusTerminated
Product CodeKRA
Date Initiated2014-08-06
Date Terminated2017-03-27
Product QuantityDomestic: 36 units

Reason for Recall

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

Firm Action

AngioDynamics sent an URGENT MEDICAL DEVICE RECALL Letter dated August 6, 2014, to all affected customers via Federal Express. Consignees were instructed to segregate and return all affected devices to AngioDynamics, Inc. and complete and return the Reply Verification Tracking Form, provided in the recall notification. Those customers with the affected product were also instructed to call AngioDynamics Customer Service at 1-800-772-6446. For questions regarding this recall call 718-742-4571.

Root Cause

Component design/selection

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961763PULSE*SPRAY INFUSION SYSTEMAngiodynamics, Div. E-Z-Em, Inc. · 1996-07-17K951602PULSE*SPRAY INFUSION SYSTEMAngiodynamics, Div. E-Z-Em, Inc. · 1995-06-14K905447E-Z-EM PULSED INFUSION SYSTEME-Z-Em, Inc. · 1991-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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