Reported Jun 26, 2024 · Ongoing
TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot),…
Outset Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Outset Medical, Inc. · 3052 Orchard Dr · San Jose, CA · 95134-2011
Is this the product you have?
- 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
- Lot codes and dates
- UDI-DI00850001011303. All PN-0006813
- serial numbers with power cords
PN-0005746PN-0006578PN-0005747
- Amount recalled
- 431
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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