TabloCart power cord connector may overheat in hemodialysis system
Outset Medical is recalling 431 TabloCart hemodialysis system carts due to power cord connector defects that may cause overheating, sparks, and smoke, potentially delaying treatment or causing burns.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device with a credible thermal hazard (sparks, heat, smoke, melting) on a critical dialysis component, but no reported injuries or illnesses have been documented. The hazard is significant but currently theoretical.
Plain-English summary
Outset Medical, Inc. is recalling 431 TabloCart units with Prefiltration Drawer (PN-0006813) used with the Tablo Hemodialysis System. The units are equipped with power cords (PN-0005746, PN-0006578, or PN-0005747) that may have defective internal contact pins.
The female connector on the power cord may have damaged internal contact pins. This damage can cause localized heat, sparks, smoke, melting, or charring (thermal events) at the connector or the associated power entry module. These thermal events could lead to transient delays in dialysis treatment or cause blistering injuries to users.
The recalled units were distributed nationwide across multiple states including 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, and Ohio.
If you have a TabloCart with this prefiltration drawer, do not use the device until you have contacted Outset Medical, Inc. or your dialysis facility. The manufacturer will provide inspection or replacement options. For additional information, visit the FDA recall notice.
The recalled product
- Product
- TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.
- Manufacturer
- Outset Medical, Inc.
- Hazard
- thermal-event
- burn-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- PN-0006578
- PN-0005747
Distribution
Distributed nationwide across the United States.
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