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PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 125...

FDA Recall #Z-1010-2024 — Class II — December 18, 2023

Recall #Z-1010-2024 Date: December 18, 2023 Classification: Class II Status: Ongoing

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.

Recalling Firm

Angiodynamics, Inc. — Queensbury, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

7 eaches

Distribution

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

Code Information

UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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