Recall Z-2260-2014— Angiodynamics, Inc.
Class II · Terminated
Class II FDA medical device recall by Angiodynamics, Inc., initiated 2014-08-06, terminated 2017-03-27. It names 3 FDA 510(k) clearances: K961763, K951602, K905447. 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. Reason: AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long)..
- Recalling firm
- Angiodynamics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-06
- Terminated
- 2017-03-27
- Firm location
- Queensbury, NY, United States
510(k) clearances named in this recall
3 on FDA's record- K961763 — PULSE*SPRAY INFUSION SYSTEM
- K951602 — PULSE*SPRAY INFUSION SYSTEM
- K905447 — E-Z-EM PULSED INFUSION SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.