Recall Z-0019-2025 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Outset Medical, Inc.
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
| Date | Oct 3, 2024 (initiated Aug 1, 2024) |
| Status | Open, Classified |
| Reason | Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath. |
| Root cause | Nonconforming Material/Component |
| Action | On 8/1/24, field action notices were sent to customers who were asked to do the following: Component replacement will be performed with routine maintenance and/or service to affected devices. To support component replacement, the device software may be upgraded, as needed. A firm's Field Service Engineer will coordinate this service with your staff to minimize device downtime. 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 transferr |
| Quantity | 2,422 |
| Distribution | US: CA, NY, IL, MO, KY, AZ, PA, FL, GA, AK, NM, VA, NC, SC, OK, AL, MA, OH, MI, WA, ID, TX, TN, WY, IA, LA, NE, IN, AR, NV, WV, CO, NJ, MD, KS, UT, CT, MN, MS, WI, HI, DE, VT, MT, OR, ND. OUS: UAE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233335 | Tablo® Hemodialysis System Outset Medical, Inc., Dec 5, 2023 |