Baxter MiniCap PD Transfer Sets Recalled for Connector Separation Risk

Agency Publication Date: November 27, 2024

Summary

Baxter Healthcare Corporation is recalling approximately 650,884 units of MiniCap Extended Life Peritoneal Dialysis (PD) Transfer Sets. The recall was initiated due to an increase in reports that the female connector can separate from the main body of the transfer set. These sets are used in peritoneal dialysis, and a separation could lead to leaks, dialysis interruption, or contamination.

Risk

If the connector separates from the transfer set, it may allow bacteria to enter the dialysis system or cause fluid leaks. This poses a risk of peritonitis (infection of the abdominal lining) or other serious infections for patients undergoing dialysis treatment.

What You Should Do

This recall affects multiple models of the Baxter MiniCap Extended Life PD Transfer Set, including variants with twist clamps or titanium spikes (Part Numbers 5C4482, 5C4482EJ, 5C4482S, 5C4483, R5C4482, R5C4482E, R5C4483, R5C4484, T5C4482, T5C4325K, and T5C4326K).
Identify if your device is affected by checking the part number and lot number printed on the device packaging or label. See the Affected Products section below for the full list of affected codes.
Stop using the recalled device. Contact Baxter Healthcare Corporation or your medical distributor immediately to arrange for the return, replacement, or correction of the affected units.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions or wish to report a concern.

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: MiniCap Extended Life PD Transfer Set with Twist Clamp (5C4482)

Variants: Twist Clamp

Model / REF:

5C4482

Lot Numbers:

H23J16074

H23K01082

H23K06107

H23K09093

H23K28051

H23K30081

H23L07053

H23L13051

H23L27093

H24A03061

H24A09035

H24A11064

H24A29132

H24B02038

H24B12086

H24B21079

H24B28090

H24B29072

H24B29098

H24C21093

H24C27090

H24D08064

H24D11050

H24D17040

H24D22081

H24D26058

H24D30076

H24E06065

H24E23037

H24E28051

H24F03045

H24F05065

H24F17086

H24F24033

H24F27036

H24H05061

H24H08032

H24H13040

H24H16043

H24H22025

UDI:

00085412007731

Recall #: Z-0559-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (5C4482EJ)

Variants: Twist Clamp

Model / REF:

5C4482EJ

Lot Numbers:

H24C19063

H24G22092

H24G25061

UDI:

00085412489643

Recall #: Z-0560-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (5C4482S)

Variants: Twist Clamp

Model / REF:

5C4482S

Lot Numbers:

H23J13063

H23J26081

H24B18059

H24B19065

H24B19099

H24B20071

H24C18065

H24E22062

H24F11048

UDI:

00085412476261

Recall #: Z-0561-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (5C4483)

Variants: Twist Clamp

Model / REF:

5C4483

Lot Numbers:

H23J10051

H23J23062

H23K20066

H24C08033

H24E16080

H24F12046

H24F17045

H24G02045

H24I02090

UDI:

00085412007748

Recall #: Z-0562-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (R5C4482)

Variants: Twist Clamp

Model / REF:

R5C4482

Lot Numbers:

H23K15033

H23K17088

H23L15049

H23L20049

H24A17046

H24A23069

H24C13090

H24D15036

H24C29493

UDI:

00085412007748

Recall #: Z-0563-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (R5C4482E)

Variants: Twist Clamp

Model / REF:

R5C4482E

Lot Numbers:

H23J18054

H24G10063

UDI:

05413760375861

Recall #: Z-0564-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (R5C4483)

Variants: Twist Clamp

Model / REF:

R5C4483

Lot Numbers:

H23J30067

UDI:

00085412008783

Recall #: Z-0565-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (R5C4484)

Variants: Twist Clamp

Model / REF:

R5C4484

Lot Numbers:

H23J23039

UDI:

00085412050768

Recall #: Z-0566-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (T5C4482)

Variants: Twist Clamp

Model / REF:

T5C4482

Lot Numbers:

H23L06097

H24A29033

UDI:

04987456422890

Recall #: Z-0567-2025

Product: MiniCap Extended Life PD Transfer Set (long) with Titanium Spike (T5C4325K)

Variants: Long, Titanium Spike

Model / REF:

T5C4325K

Lot Numbers:

H24E15066

UDI:

0085412150710

Recall #: Z-0568-2025

Product: MiniCap Extended Life PD Transfer Set (short) with Titanium Spike (T5C4326K)

Variants: Short, Titanium Spike

Model / REF:

T5C4326K

Lot Numbers:

H23J02025

H23L04043

H23L05057

H23L05073

H24A29041

H24C01061

H24E13061

H24G15062

UDI:

0085412150703

Recall #: Z-0569-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95524

Status: Active

Manufacturer: Baxter Healthcare Corporation

Sold By: Baxter Healthcare Corporation; Medical distributors

Manufactured In: United States

Units Affected: 11 products (409464 units; 22392 units; 31248 units; 62,718; 83,448 units; 13,608 units; 8,394 units; 3204 units; 1496 units; 1536 units; 13376 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, including variants with twist clamps or titanium spikes (Part Numbers 5C4482, 5C4482EJ, 5C4482S, 5C4483, R5C4482, R5C4482E, R5C4483, R5C4484, T5C4482, T5C4325K, and T5C4326K).

Identify if your device is affected by checking the part number and lot number printed on the device packaging or label. See the Affected Products section below for the full list of affected codes.

Stop using the recalled device. Contact Baxter Healthcare Corporation or your medical distributor immediately to arrange for the return, replacement, or correction of the affected units.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions or wish to report a concern.

Affected Products

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (5C4482)

Variants: Twist Clamp

Model / REF:

5C4482

Lot Numbers:

H23J16074

H23K01082

H23K06107

H23K09093

H23K28051

H23K30081

H23L07053

H23L13051

H23L27093

H24A03061

H24A09035

H24A11064

H24A29132

H24B02038

H24B12086

H24B21079

H24B28090

H24B29072

H24B29098

H24C21093

H24C27090

H24D08064

H24D11050

H24D17040

H24D22081

H24D26058

H24D30076

H24E06065

H24E23037

H24E28051

H24F03045

H24F05065

H24F17086

H24F24033

H24F27036

H24H05061

H24H08032

H24H13040

H24H16043

H24H22025

UDI:

00085412007731

Recall #: Z-0559-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (5C4482EJ)

Variants: Twist Clamp

Model / REF:

5C4482EJ

Lot Numbers:

H24C19063

H24G22092

H24G25061

UDI:

00085412489643

Recall #: Z-0560-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (5C4482S)

Variants: Twist Clamp

Model / REF:

5C4482S

Lot Numbers:

H23J13063

H23J26081

H24B18059

H24B19065

H24B19099

H24B20071

H24C18065

H24E22062

H24F11048

UDI:

00085412476261

Recall #: Z-0561-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (5C4483)

Variants: Twist Clamp

Model / REF:

5C4483

Lot Numbers:

H23J10051

H23J23062

H23K20066

H24C08033

H24E16080

H24F12046

H24F17045

H24G02045

H24I02090

UDI:

00085412007748

Recall #: Z-0562-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (R5C4482)

Variants: Twist Clamp

Model / REF:

R5C4482

Lot Numbers:

H23K15033

H23K17088

H23L15049

H23L20049

H24A17046

H24A23069

H24C13090

H24D15036

H24C29493

UDI:

00085412007748

Recall #: Z-0563-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (R5C4482E)

Variants: Twist Clamp

Model / REF:

R5C4482E

Lot Numbers:

H23J18054

H24G10063

UDI:

05413760375861

Recall #: Z-0564-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (R5C4483)

Variants: Twist Clamp

Model / REF:

R5C4483

Lot Numbers:

H23J30067

UDI:

00085412008783

Recall #: Z-0565-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (R5C4484)

Variants: Twist Clamp

Model / REF:

R5C4484

Lot Numbers:

H23J23039

UDI:

00085412050768

Recall #: Z-0566-2025

Product: MiniCap Extended Life PD Transfer Set with Twist Clamp (T5C4482)

Variants: Twist Clamp

Model / REF:

T5C4482

Lot Numbers:

H23L06097

H24A29033

UDI:

04987456422890

Recall #: Z-0567-2025

Product: MiniCap Extended Life PD Transfer Set (long) with Titanium Spike (T5C4325K)

Variants: Long, Titanium Spike

Model / REF:

T5C4325K

Lot Numbers:

H24E15066

UDI:

0085412150710

Recall #: Z-0568-2025

Product: MiniCap Extended Life PD Transfer Set (short) with Titanium Spike (T5C4326K)

Variants: Short, Titanium Spike

Model / REF:

T5C4326K

Lot Numbers:

H23J02025

H23L04043

H23L05057

H23L05073

H24A29041

H24C01061

H24E13061

H24G15062

UDI:

0085412150703

Recall #: Z-0569-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95524

Status: Active

Manufacturer: Baxter Healthcare Corporation

Sold By: Baxter Healthcare Corporation; Medical distributors

Manufactured In: United States

Units Affected: 11 products (409464 units; 22392 units; 31248 units; 62,718; 83,448 units; 13,608 units; 8,394 units; 3204 units; 1496 units; 1536 units; 13376 units)

Distributed To: Nationwide