Angiodynamics, Inc.: PulseSpray Infusion Systems Recalled for O-Ring Defect and Leakage Risk

Agency Publication Date: February 7, 2024

Summary

AngioDynamics is recalling 7 units of its PulseSpray Infusion System due to a manufacturing defect in the rotating adaptor's O-ring. This defect can compromise the seal's integrity, which may result in a medication leak during a patient's infusion procedure. The recall affects three specific models of the PulseSpray system: 5F/135/20, 3Fx135x20, and 5F/45/10. Consumers and healthcare providers should check their inventory for the specific lot numbers affected to prevent patient harm.

Risk

A faulty O-ring can cause the device to leak medication during use, potentially leading to an incomplete treatment dose or exposing clinical staff to the infused medication.

What You Should Do

Immediately check your medical inventory for PulseSpray Infusion Systems with the following identifiers: REF 12500404 (Lot 5795345), REF 12500415 (Lot 5793480), or REF 12500423 (Lot 5795344).
Identify the affected products by checking the UDI-DI on the packaging: 15051684013109, 15051684013215, or 15051684013291.
If you possess any of these specific lots, stop using them immediately and set them aside to ensure they are not used in clinical procedures.
Contact your healthcare provider or AngioDynamics, Inc. at their Queensbury, New York facility for further instructions and information regarding the return or replacement of these devices.
For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and potential return.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: PULSE SPRAY 5F/135/20

Model / REF:

REF: 12500404

UPN: H787125004045

UPC Codes:

15051684013109

Lot Numbers:

5795345

Product: Pulse Spray 3Fx135x20

Model / REF:

REF: 12500415

UPN: H787125004155

UPC Codes:

15051684013215

Lot Numbers:

5793480

Product: PULSE SPRAY 5F/45/10

Model / REF:

REF: 12500423

UPN: H787125004235

UPC Codes:

15051684013291

Lot Numbers:

5795344

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93744

Status: Active

Manufacturer: Angiodynamics, Inc.

Sold By: Medical distributors; Direct hospital sales

Manufactured In: United States

Units Affected: 7 eaches

Distributed To: Maryland, Louisiana, Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Immediately check your medical inventory for PulseSpray Infusion Systems with the following identifiers: REF 12500404 (Lot 5795345), REF 12500415 (Lot 5793480), or REF 12500423 (Lot 5795344).

Identify the affected products by checking the UDI-DI on the packaging: 15051684013109, 15051684013215, or 15051684013291.

If you possess any of these specific lots, stop using them immediately and set them aside to ensure they are not used in clinical procedures.

Contact your healthcare provider or AngioDynamics, Inc. at their Queensbury, New York facility for further instructions and information regarding the return or replacement of these devices.

For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: PULSE SPRAY 5F/135/20

Model / REF:

REF: 12500404

UPN: H787125004045

UPC Codes:

15051684013109

Lot Numbers:

5795345

Product: Pulse Spray 3Fx135x20

Model / REF:

REF: 12500415

UPN: H787125004155

UPC Codes:

15051684013215

Lot Numbers:

5793480

Product: PULSE SPRAY 5F/45/10

Model / REF:

REF: 12500423

UPN: H787125004235

UPC Codes:

15051684013291

Lot Numbers:

5795344