—#205352

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.

FDA product code: KRA — Catheter, Continuous Flush
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K163356
Affected lot / code info: UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

An Urgent Medical Voluntary Medical Device notices dated December 18, 2023 was issued to distributors and end users with instructions to immediately stop using affected product, remove said product from inventory and return to AngioDynamics, Inc. The notice should be forwarded to all site affected product may have been distributed to and recipients are asked to complete and return the Reply Verification Tracking Form. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.

Recalling firm

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

Distribution

Distribution pattern: United States (MD, LA & UT), Austria, Canada and Spain.

Timeline

Recall initiated: 2023-12-18
Posted by FDA: 2024-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205352. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.