Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Reported: April 24, 2024 Initiated: March 6, 2024 #Z-1485-2024
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.
Details
- Recalling Firm
- Outset Medical, Inc.
- Units Affected
- 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
- Location
- San Jose, CA
Frequently Asked Questions
What product was recalled? ▼
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001. Recalled by Outset Medical, Inc.. Units affected: 919.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2024. Severity: Critical. Recall number: Z-1485-2024.
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