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.
Enforcement
- Recall Number
- Z-2150-2024
- Event ID
- 94654
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Outset Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 26, 2024
- Initiation Date
- April 30, 2024
- Classification Date
- June 14, 2024
- Address
- 3052 Orchard Dr, N/A, San Jose, CA, 95134-2011, United States
Description
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.
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.
UDI-DI: 00850001011303. All PN-0006813 serial numbers with power cords: PN-0005746, PN-0006578, PN-0005747
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.
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