Class 2 Device Recall The The TabloCart with prefiltration drawer

• Date Initiated by Firm: April 30, 2024
• Date Posted: June 14, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2150-2024
• Recall Event ID: 94654
• 510(K)Number: K232776 K233335
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• 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.
• Code Information: UDI-DI: 00850001011303. All PN-0006813 serial numbers with power cords: PN-0005746, PN-0006578, PN-0005747
• FEI Number: 3010355846
• Recalling Firm/ Manufacturer: Outset Medical, Inc.; 3052 Orchard Dr; San Jose CA 95134-2011
• For Additional Information Contact: Lance Mattoon; 669-231-8200
• Manufacturer 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.
• FDA Determined 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 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.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KDI