Outset Medical, Inc.: 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 w

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of FL, CA, NC, GA, MD, DE, AK, OK, MA, WV, IN, KY, AZ, LA, NE, KS, NJ, CT, NM, CO, SC, TX, PA, NY, OH. Quantity: 431 Lot/code info: UDI-DI: 00850001011303. All PN-0006813 serial numbers with power cords: PN-0005746, PN-0006578, PN-0005747

UPC codes

00850001011303

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.