Z-2150-2024Class II

TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot)...

Name: Z-2150-2024 TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot)...
Creator: Outset Medical, Inc.
Published: 2024-04-30
License: https://open.fda.gov/license/

Outset Medical, Inc. / initiated 2024-04-30 / Open, Classified / root cause: design

FDA source

Outset Medical, Inc. began a recall of 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... on 2024-04-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2150-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-30
Posted: 2024-06-14
Recalling firm: Outset Medical, Inc.
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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 431
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 codes and lots: UDI-DI: 00850001011303. All PN-0006813 serial numbers with power cords: PN-0005746, PN-0006578, PN-0005747

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2150-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2150-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-14

Product code KDI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)