Baxter MiniCap PD Transfer Sets Recalled for Potential Chemical Exposure

Agency Publication Date: November 20, 2024

Summary

Baxter Healthcare Corporation has recalled 3,789,172 MiniCap Extended Life Peritoneal Dialysis (PD) Transfer Sets. These devices, which are used to manage fluid exchange during dialysis, are being recalled because of a potential risk of patient exposure to certain chemicals (PCBAs and PCBs) that may leach from the device components. While no injuries or incidents have been reported to date, Baxter is taking this action following similar recalls by other dialysis equipment manufacturers.

Risk

Patients using these transfer sets may be exposed to non-dioxin-like polychlorinated biphenyls and acids. This chemical exposure can occur when substances leach into the dialysis solution, potentially posing long-term health risks to patients receiving treatment.

What You Should Do

This recall affects multiple models of the Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, including part numbers 5C4482, 5C4482EJ, 5C4482S, 5C4483, R5C4482, R5C4482E, R5C4483, R5C4484, T5C4482, and T5C4484. See the Affected Products section below for the full list of affected codes.
Stop using the recalled device.
Contact Baxter Healthcare Corporation or your authorized medical distributor to arrange for a return, replacement, or correction of the affected sets.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

5C4482

Lot Numbers:

All lots including and manufactured after H19I26088

UDI:

00085412007731

Used in Peritoneal Dialysis; Recall #: Z-0373-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

5C4482EJ

Lot Numbers:

All lots including and manufactured after H20A30068

UDI:

00085412489643

Used in Peritoneal Dialysis; Recall #: Z-0374-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

5C4482S

Lot Numbers:

All lots including and manufactured after H19J11055

UDI:

00085412476261

Used in Peritoneal Dialysis; Recall #: Z-0375-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

5C4483

Lot Numbers:

All lots manufactured between and including H19J14422 and H24F17045

UDI:

00085412007748

Used in Peritoneal Dialysis; Recall #: Z-0376-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

R5C4482

Lot Numbers:

All lots including and manufactured after H19J22078

UDI:

00085412007748

Used in Peritoneal Dialysis; Recall #: Z-0377-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

R5C4482E

Lot Numbers:

All lots including and manufactured after H19K04041

UDI:

05413760375861

Used in Peritoneal Dialysis; Recall #: Z-0378-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

R5C4483

Lot Numbers:

All lots including and manufactured after H19J21062

UDI:

00085412008783

Used in Peritoneal Dialysis; Recall #: Z-0379-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

R5C4484

Lot Numbers:

All lots including and manufactured after H20B11116

UDI:

00085412050768

Used in Peritoneal Dialysis; Recall #: Z-0380-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

T5C4482

Lot Numbers:

All lots including and manufactured after H20F09053

UDI:

04987456422890

Used in Peritoneal Dialysis; Recall #: Z-0381-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short

Model / REF:

T5C4484

Lot Numbers:

All lots including and manufactured after H20B11074

UDI:

00085412008783

Used in Peritoneal Dialysis; Recall #: Z-0382-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95525

Status: Active

Manufacturer: Baxter Healthcare Corporation

Sold By: Authorized Medical Distributors; Hospitals; Dialysis Clinics

Manufactured In: United States

Units Affected: 10 products (2,706,558 units; 56,304 units; 151,020 units; 319,308 units; 410,862 units; 58,680 units; 62,394 units; 18,426 units; 4,380 units; 1,240 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects multiple models of the Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, including part numbers 5C4482, 5C4482EJ, 5C4482S, 5C4483, R5C4482, R5C4482E, R5C4483, R5C4484, T5C4482, and T5C4484. See the Affected Products section below for the full list of affected codes.

Stop using the recalled device.

Contact Baxter Healthcare Corporation or your authorized medical distributor to arrange for a return, replacement, or correction of the affected sets.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or questions regarding this recall.

Affected Products

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

5C4482

Lot Numbers:

All lots including and manufactured after H19I26088

UDI:

00085412007731

Used in Peritoneal Dialysis; Recall #: Z-0373-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

5C4482EJ

Lot Numbers:

All lots including and manufactured after H20A30068

UDI:

00085412489643

Used in Peritoneal Dialysis; Recall #: Z-0374-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

5C4482S

Lot Numbers:

All lots including and manufactured after H19J11055

UDI:

00085412476261

Used in Peritoneal Dialysis; Recall #: Z-0375-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

5C4483

Lot Numbers:

All lots manufactured between and including H19J14422 and H24F17045

UDI:

00085412007748

Used in Peritoneal Dialysis; Recall #: Z-0376-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

R5C4482

Lot Numbers:

All lots including and manufactured after H19J22078

UDI:

00085412007748

Used in Peritoneal Dialysis; Recall #: Z-0377-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

R5C4482E

Lot Numbers:

All lots including and manufactured after H19K04041

UDI:

05413760375861

Used in Peritoneal Dialysis; Recall #: Z-0378-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

R5C4483

Lot Numbers:

All lots including and manufactured after H19J21062

UDI:

00085412008783

Used in Peritoneal Dialysis; Recall #: Z-0379-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

R5C4484

Lot Numbers:

All lots including and manufactured after H20B11116

UDI:

00085412050768

Used in Peritoneal Dialysis; Recall #: Z-0380-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

Model / REF:

T5C4482

Lot Numbers:

All lots including and manufactured after H20F09053

UDI:

04987456422890

Used in Peritoneal Dialysis; Recall #: Z-0381-2025

Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short

Model / REF:

T5C4484

Lot Numbers:

All lots including and manufactured after H20B11074

UDI:

00085412008783

Used in Peritoneal Dialysis; Recall #: Z-0382-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95525

Status: Active

Manufacturer: Baxter Healthcare Corporation

Sold By: Authorized Medical Distributors; Hospitals; Dialysis Clinics

Manufactured In: United States

Units Affected: 10 products (2,706,558 units; 56,304 units; 151,020 units; 319,308 units; 410,862 units; 58,680 units; 62,394 units; 18,426 units; 4,380 units; 1,240 units)

Distributed To: Nationwide