Outset Medical, Inc.: TabloCart Prefiltration Drawers Recalled for Fire and Burn Hazards

Agency Publication Date: June 14, 2024

Summary

Outset Medical is recalling 431 units of the TabloCart with Prefiltration Drawer, which is an optional accessory for the Tablo Hemodialysis System. The recall involves carts with part number PN-0006813 used with specific 10-foot, 15-foot, and 20-foot power cords. The internal contact pins in the power cord's connector can become damaged, causing the cord to overheat, spark, smoke, or melt. This defect could result in skin blistering for the user or cause a temporary delay in necessary dialysis treatment.

Risk

Damaged pins in the power cord connector can create localized heat or sparks, leading to a fire hazard or melting of the device components. This poses a risk of burn injuries to the user and can cause the hemodialysis system to lose power, potentially interrupting critical medical care.

What You Should Do

Check your device to see if you have the TabloCart with Prefiltration Drawer (Part Number PN-0006813).
Verify if your unit uses any of the following affected power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), or PN-0005747 (20-foot).
Identify the device using the UDI-DI code 00850001011303 located on the product labeling.
Contact Outset Medical at their San Jose headquarters or your healthcare provider immediately for instructions on how to handle the device and to learn about available repairs or replacements.
If you experience any issues with the power cord such as smoke, heat, or charring, stop use immediately if it is safe to do so and contact your healthcare provider.
For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

manufacturer or healthcare provider Consultation

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

Affected Products

Product: TabloCart with Prefiltration Drawer PN-0006813

Model / REF:

PN-0006813

Lot Numbers:

PN-0005746 (10-foot cord)

PN-0006578 (15-foot cord)

PN-0005747 (20-foot cord)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94654

Status: Active

Manufacturer: Outset Medical, Inc.

Sold By: Healthcare facilities; Direct distribution

Manufactured In: United States

Units Affected: 431

Distributed To: Florida, California, North Carolina, Georgia, Maryland, Delaware, Alaska, Oklahoma, Massachusetts, West Virginia, Indiana, Kentucky, Arizona, Louisiana, Nebraska, Kansas, New Jersey, Connecticut, New Mexico, Colorado, South Carolina, Texas, Pennsylvania, New York, Ohio

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

Check your device to see if you have the TabloCart with Prefiltration Drawer (Part Number PN-0006813).

Verify if your unit uses any of the following affected power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), or PN-0005747 (20-foot).

Identify the device using the UDI-DI code 00850001011303 located on the product labeling.

Contact Outset Medical at their San Jose headquarters or your healthcare provider immediately for instructions on how to handle the device and to learn about available repairs or replacements.

If you experience any issues with the power cord such as smoke, heat, or charring, stop use immediately if it is safe to do so and contact your healthcare provider.

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