Recall Z-2261-2014 ยท KRA Catheter, Continuous Flush
Angiodynamics, Inc.
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
| Date | Aug 18, 2014 (initiated Aug 6, 2014) |
| Status | Terminated |
| 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: 81 units; Foreign: 13 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland. |
| FDA record | Open on fda.gov |