Outset Medical recalls TabloCart with Prefiltration Drawer (PN-0006813) with specific power cords due to potential electrical hazards from damaged connectors that could cause heat, sparks, or fire. Affected units may need replacement.
A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or the associated connector power entry module, which may lead to transient delay in treatment or blistering to the user.
Outset Medical is recalling TabloCart devices with prefiltration drawers and specific power cords because damaged internal connectors could cause heat, sparks, or fire, potentially delaying dialysis treatment or causing burns. This is a safety issue that requires immediate attention to prevent injury.
The power cord's female connector has internal contact pins that can become damaged, leading to localized heat, sparks, smoke, or melting. This could cause temporary treatment delays or burns to the user, especially during dialysis procedures.
Healthcare professionals using the TabloCart with prefiltration drawer for hemodialysis treatments are most at risk. Patients receiving dialysis through this equipment could be affected if the device malfunctions.
Check for the TabloCart with Prefiltration Drawer (PN-0006813) with power cords labeled PN-0005746 (10-foot), PN-0006578 (15-foot), or PN-0005747 (20-foot). The device was sold with a unique identifier (UDI-DI: 00850001011303).
Verify the product's serial number matches the recalled units (PN-0006813 with specific power cords).
If the device is affected, stop using it to prevent potential electrical hazards.
The power cord's female connector has internal contact pins that can become damaged, leading to localized heat, sparks, smoke, or melting, which could cause treatment delays or burns.
Check the device's serial number and power cord model. If it matches the recalled units, stop using it immediately and contact Outset Medical for instructions.
The recall states that damaged connectors could cause temporary treatment delays or burns, but the remedy is not specified in the record.
We’ve drafted a message you can send Outset Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2150-2024 — Outset Medical Outset Medical Hello, I own a Outset Medical that is covered by recall Z-2150-2024 from Outset Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
