Recall Z-2150-2024 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Outset Medical, Inc.
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.
| Date | Jun 14, 2024 (initiated Apr 30, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |