FDA Medical Device Recalls (openFDA)
Angiodynamics, Inc.: 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
- Recall number
- Z-2260-2014
- Recalling firm
- Angiodynamics, Inc.
- 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
- Status
- Terminated
- Initiated
- 2014-08-06
- Posted
- 2014-08-18
- Terminated
- 2017-03-27
- Reason
- AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
- 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
- Domestic: 70 units; Foreign: 27 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.
- Lot, serial or model codes
- Lot 4731639 (exp. date 31-Mar-17)
- 510(k) numbers
- ["K905447","K951602","K961763"]
- PMA numbers
- not on file
- Product code
- KRA
- Firm FEI
- 1319211
- Firm city
- Queensbury
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28