Recall Z-1485-2024 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Outset Medical, Inc.
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
| Date | Apr 12, 2024 (initiated Mar 6, 2024) |
| Status | Open, Classified |
| Reason | Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans. |
| Root cause | Device Design |
| Action | On 3/6/24, correction notices were mailed to customers who were informed that the firm has qualified silicone tubing manufactured with a platinum initiator (platinum-cured) replacement to eliminate the presence of NDL-PCBAs. Field Service Engineers service starting in March 2024. Customers were asked to do the following: 1) 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. 2) Identify and notify your home patients that were |
| Quantity | 919 |
| Distribution | US:FL, CA, NM, SC, AZ, TN, NC, TX, IL, MD, IN, DE, AL, MI, AK, KY, LA, ID, OK, IA, VA, GA, MA, NE, KS, WI, PA, OH, WA, MT, RI, MN, MO, AR, NY, CO, WV, SD, OR, UT, WY, DC. OUS: AE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233335 | Tablo® Hemodialysis System Outset Medical, Inc., Dec 5, 2023 |