TabloCart with Prefiltration Drawer PN-0006813, with power… recallZ-2150-2024 · Outset Medical, Inc. · initiated Apr 30, 2024
Class II Open, Classified All recalls posted in June 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Outset Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Device Design
What the company is doing
On 4/30/24, correction notices were sent to customers asking them to do the following: The firm has enclosed the replacement power cord (PN-0008460) with this communication based on the number of affected devices at your facility. Disseminate this information to appropriate personnel within your facility for processing and distribution. This notice should be shared with any organization where the potentially affected devices have been transferred. Follow instructions to replace the power cords. Dispose of the affected power cords. Complete and return the acknowledgement and receipt form via email to [email protected] If you have questions or notice any damage around the power cord, please contact us at [email protected] or 844-MYTABLO (844-698-2256) and request an inspection from a Field Service Engineer.
Recall details
- Recall number
- Z-2150-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Apr 30, 2024
- Posted by the FDA
- Jun 14, 2024
- Recalling firm
- Outset Medical, Inc.
- Quantity
- 431
- Product code
- KDI
- FDA submissions
- K232776, K233335
- 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.
Product 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.
Code information (models, lots, serial numbers)
UDI-DI: 00850001011303. All PN-0006813 serial numbers with power cords: PN-0005746, PN-0006578, PN-0005747
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TabloCart™ with Prefiltration Drawer PN-0006813Outset Medical, Inc. · Subsystem, Water Purification1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K232776, K233335 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Tablo(R) Hemodialysis System PN-0006000Outset Medical, Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System4 recalls8 deaths46 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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