Medical Device Recall: Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Outset Medical, Inc. · March 6, 2024
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.
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
States Affected
AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY
Quantity Affected
919
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1485-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.