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:
- 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
- MiniCap Extended Life PD Transfer Set with Twist Clamp
What to Do
- Do not stop dialysis treatment or routine transfer set replacements for people who need them.
- Switch to platinum-cured silicone tubing versions of these transfer sets when they become available.
On October 21, 2024, Baxter sent all affected customers an Important Medical Device Correction letter recommending the following actions:
- Continue providing dialysis treatments to patients as peritoneal dialysis systems are critical to patient care.
- Do not replace current MiniCap Extended Life PD Transfer Sets (those with peroxide cured silicone tubing) early as data demonstrates that PCB and PCBA levels decrease over treatment time.
- Use platinum-cured silicone tubing versions of the MiniCap Extended Life PD transfer sets once they are available.
- 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 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 and check the associated box in the customer portal.
Reason for Correction
Baxter is correcting MiniCap Extended Life PD Transfer Sets 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 MiniCap Extended Life PD Transfer Sets. The company is also transitioning certain components in the sets 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 MiniCap Extended Life PD Transfer Sets are used during peritoneal dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution bag.
Contact Information
Customers in the U.S. with questions about this recall should contact Baxter Renal Customer Care at 800-284-4060, press option 3.
Additional FDA Resources
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.
