Sam Brusco, Associate Editor04.25.24
The U.S. Food and Drug Administration (FDA) has identified Outset Medical’s recall of some Tablo hemodialysis devices as Class I.
The company recalled the devices after identifying non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching at levels above allowable safety limits. The NDL-PCBAs came from the peroxide-cured silicone tubing used in the machine’s hydraulics and for dialysate lines.
Patients are at risk of higher than allowable exposure limits of the compounds from the dialysate solution.
The company discovered that NDL-PCBAs leaching lessens over time and reduce to an acceptable safety level after 336 hours of operational use. Outset said the recall aims to change the affected tubing for consoles in use for less than 336 hours.
NDL-PCBAs are an acid of NDL-PCBs. Exposure to NDL-PCBs or NDL-PCB related compounds can cause adverse health consequences months to years after exposure, including endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), and male infertility.
There have been no injuries or deaths reported as a result of this issue. Outset said the recall is a correction, not a product removal.
In its March 6 Urgent Medical Device Correction Letter, Outset advised to consider alternative machines if customers have a new Tablo hemodialysis system. If only new systems are available, continued use was recommended so patients still have access to dialysis, until the devices are serviced.
Outset also advised examining inventory for device serial numbers—devices beginning with serial number 604572M were manufactured with platinum-cured tubing and aren’t affected.
Tablo functions as an artificial kidney system and can provide the following treatment types: intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED/ SLEDD), prolonged intermittent renal replacement therapy (PIRRT), and isolated ultrafiltration.
The company recalled the devices after identifying non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching at levels above allowable safety limits. The NDL-PCBAs came from the peroxide-cured silicone tubing used in the machine’s hydraulics and for dialysate lines.
Patients are at risk of higher than allowable exposure limits of the compounds from the dialysate solution.
The company discovered that NDL-PCBAs leaching lessens over time and reduce to an acceptable safety level after 336 hours of operational use. Outset said the recall aims to change the affected tubing for consoles in use for less than 336 hours.
NDL-PCBAs are an acid of NDL-PCBs. Exposure to NDL-PCBs or NDL-PCB related compounds can cause adverse health consequences months to years after exposure, including endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), and male infertility.
There have been no injuries or deaths reported as a result of this issue. Outset said the recall is a correction, not a product removal.
In its March 6 Urgent Medical Device Correction Letter, Outset advised to consider alternative machines if customers have a new Tablo hemodialysis system. If only new systems are available, continued use was recommended so patients still have access to dialysis, until the devices are serviced.
Outset also advised examining inventory for device serial numbers—devices beginning with serial number 604572M were manufactured with platinum-cured tubing and aren’t affected.
About the Tablo hemodialysis system
The Tablo hemodialysis system is for use in patients with acute kidney failure, chronic kidney failure, or both. It’s used in healthcare facilities or in the home by those trained in the system’s use.Tablo functions as an artificial kidney system and can provide the following treatment types: intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED/ SLEDD), prolonged intermittent renal replacement therapy (PIRRT), and isolated ultrafiltration.