TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747

FDA device recall Z-2150-2024 · posted 2024-06-14 · Open, Classified

Recall details

Recalling firm

Outset Medical, Inc.

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.

Action taken

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 FieldActionAdvisory@OutsetMedical.com If you have questions or notice any damage around the power cord, please contact us at support@outsetmedical.com or 844-MYTABLO (844-698-2256) and request an inspection from a Field Service Engineer.

Root cause

Device Design

Status

Open, Classified

Product code

KDI

Quantity affected

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.

Date initiated

2024-04-30

Date posted

2024-06-14

Location

San Jose, CA

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