Recall Z-1485-2024— Outset Medical, Inc.
Class I · Ongoing
Class I FDA medical device recall by Outset Medical, Inc., initiated 2024-03-06. It names one FDA 510(k) clearance: K233335. Product: Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001. 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..
- Recalling firm
- Outset Medical, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-03-06
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.