This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
- Product Name: AK 98 Hemodialysis Machine
- Unique Device Identifier (UDI)/Product Code: 7332414124519/955607
- Serial Numbers: All serials with runtime less than 500 hours
What to Do
- Do not stop dialysis treatment for people who need it.
- If possible, do not use AK 98 Hemodialysis machines with less than 500 hours of run time.
On October 16, 2024, Baxter sent all affected customers an Important Medical Device Correction letter recommending the following actions:
- Do not stop dialysis treatment for patients who need it.
- Consider using alternative hemodialysis machines (including AK 98 machines with 500-plus runtime hours) if AK 98 machines are new with a runtime of less than 500 hours.
- Continue using machines with runtime of less than 500 hours if only these machines are available to ensure patients have access to dialysis.
- Contact Baxter Renal Customer Care to provide serial numbers for AK 98 machines with runtime of less than 500 hours and make a correction plan.
- Baxter Renal Customer Care can be reached at 800-525-2623, option 2, option 2, between the hours of 7:00 am and 5:00 pm Central Time, Monday through Friday.
- Contact Baxter Renal Customer Care if there is a medical need that requires the order of a new AK 98 machine before peroxide-cured silicone tubing has been eliminated.
- Acknowledge receipt of the notice on the customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com if communication came directly from Baxter, even if you do not have any remaining inventory.
- If product was purchased from a distributor, respond to the supplier according to their instructions.
- Forward a copy of this notice to any facilities that may have received this product.
- Dealers, wholesalers, distributor/resellers, and original equipment manufacturers that distributed product to facilities should notify customers of this notice.
Reason for Correction
Baxter is correcting AK 98 dialysis machines based on recent recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. Baxter is in the process of evaluating whether the source of PCBAs and/or NDL PCBs in those recalls (the silicone tubing manufacturing process using a chlorinated peroxide initiator) is present in AK 98 dialysis machines. The company is also transitioning certain components in these machines from peroxide-cured silicone tubing to platinum-cured silicone tubing. NDL PCBAs and NDL PCBs are not detected in medical devices with this modified version of silicone tubing.
The use of affected product may cause serious adverse health consequences months to years after exposure, including endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), male infertility, and death.
There have been no reported injuries and no reports of death.
Device Use
The Baxter AK 98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments for people with long-term (chronic) or short-term (acute) kidney (renal) failure or fluid overload. The AK 98 dialysis machine is indicated for use with patients who weigh 25 kg or more. It is used by trained operators in a chronic care dialysis or hospital care environment when prescribed by a physician.
Contact Information
Customers in the U.S. with questions about this recall should contact Baxter Renal Customer Care at 800-525-2623, press option 2, then press option 2 again.
Additional FDA Resources (listed in order of most to least recent):
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
