Z-2262-2014Class II

Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809...

Name: Z-2262-2014 Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809...
Creator: Angiodynamics, Inc.
Published: 2014-08-06
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2014-08-06 / Terminated / root cause: design

FDA source

Angiodynamics, Inc. began a recall of 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... on 2014-08-06. FDA classified it as Class II and gives the reason as "AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2262-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-06
Posted: 2014-08-18
Terminated: 2017-03-27
Recalling firm: Boston Scientific Corporation
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
Product code: KRA Catheter, Continuous Flush
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).
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: Domestic: 36 units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.
Product codes and lots: Lot 4762513 (exp. date 31-May-17)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2262-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2260-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-18
Z-2261-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-18
Z-2262-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-18

Product code KRA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)