Recall Z-1010-2024— Angiodynamics, Inc.

Name: FDA recall Z-1010-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-18

Class II · Ongoing

Class II FDA medical device recall by Angiodynamics, Inc., initiated 2023-12-18. It names one FDA 510(k) clearance: K163356. Product: PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.. Reason: Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication..

Recalling firm: Angiodynamics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-18
Firm location: Queensbury, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K163356 — Pulse* Spray Infusion System, Uni*Fuse Infusion SystemAngioDynamics, Inc.·cleared 2017-05-30

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

PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.

Reason for recall

Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.

Data sourced from openFDA. This site is unofficial and independent of the FDA.