—#129196

Product

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

FDA product code: KRA — Catheter, Continuous Flush
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K905447, K951602, K961763
Affected lot / code info: Lot 4731641 (exp. date 31-Mar-17)

Why it was recalled

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

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Angiodynamics, Inc.
Address: 603 Queensbury Ave, Queensbury, New York 12804-7619

Distribution

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

Timeline

Recall initiated: 2014-08-06
Posted by FDA: 2014-08-18
Terminated: 2017-03-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129196. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.