Correction of Peritoneal Dialysis Set: Baxter Addresses MiniCap Extended Life Transfer Sets for Higher Risk of Patient Exposure to Toxic Levels of NDL-PCBA and/or NDL-PCBs

Correction of Peritoneal Dialysis Set: Baxter Addresses MiniCap Extended Life Transfer Sets for Higher Risk of Patient Exposure to Toxic Levels of NDL-PCBA and/or NDL-PCBs

This recall is focused on rectifying certain devices rather than removing them from their usage locations. The FDA has classified this recall as the most severe category. Continued use without correction may lead to serious injury or fatality.

Product Under Recall

  • Product Name:
    • MiniCap Extended Life PD Transfer Set with Twist Clamp
    • MiniCap Extended Life PD Transfer Set with Twist Clamp – Extra Short
  • Unique Device Identifier (UDI)/Product Code/Lot Numbers:
    • MiniCap Extended Life PD Transfer Set with Twist Clamp
      • 0085412007731/5C4482/All lots within expiry
    • MiniCap Extended Life PD Transfer Set with Twist Clamp – Extra Short
      • 0085412007748/ 5C4483/ Lot H24F17045 and lower

Recommended Actions

  • Do not discontinue dialysis treatments or routine changes for patients requiring them.
  • Transition to platinum-cured silicone tubing versions of these transfer sets as they become available.

On October 21, 2024, Baxter communicated to all affected customers via an Important Medical Device Correction letter, advising the following measures:

  • Maintain dialysis treatments as peritoneal dialysis systems are crucial for patient care.
  • Do not prematurely replace current MiniCap Extended Life PD Transfer Sets (those using peroxide-cured silicone tubing) as data shows PCB and PCBA levels decrease with duration of use.
  • Utilize platinum-cured silicone tubing versions of the MiniCap Extended Life PD transfer sets once they are available.
  • Confirm receipt of the notice on the customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com if directly notified by Baxter, even without inventory.
  • If obtained from a distributor, follow their guidance.
  • Disseminate a copy of this notice to any associated facilities that received this product.
  • Distributors, wholesalers, and original equipment manufacturers should inform customers about this notification.

Justification for Correction

Baxter initiated the correction for MiniCap Extended Life PD Transfer Sets due to recent recalls by other manufacturers related to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) exposure risks with certain peritoneal dialysis and hemodialysis devices. The company is assessing whether the PCBAs and NDL PCBs present in those recalls relate to the silicone tubing manufacturing process, which employs a chlorinated peroxide initiator. Baxter is transitioning components in these sets from peroxide-cured silicone to platinum-cured silicone, where NDL PCBAs and NDL PCBs are not detected.

Utilization of the impacted product could result in severe health risks occurring from months to years post-exposure, including endocrine disruption, liver ailments, neurobehavioral issues, dermal conditions (acne, rashes), male infertility, and potential mortality.

No injuries or fatalities related to this issue have been reported.

Device Purpose

The Baxter MiniCap Extended Life PD Transfer Sets are designed for use in peritoneal dialysis therapy, facilitating the transfer of peritoneal dialysis solution from the source solution bag to the patient catheter.

For Inquiries

US customers with questions regarding this recall are encouraged to contact Baxter Renal Customer Care at 800-284-4060, selecting option 3.

Further FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) provides a way to identify individual medical devices throughout their lifecycle in the United States. It enhances the accuracy of adverse event reporting, facilitating quicker identification and resolution of device-related issues.

Reporting Issues

Health care providers and consumers can report adverse reactions or quality issues linked to these devices through MedWatch: The FDA’s Safety Information and Adverse Event Reporting Program.