Lower risk Medical device recall · FDA · Published October 21, 2024

Baxter MiniCap PD Transfer Set Recall: PCB Exposure Risk in Peritoneal Dialysis

Baxter recalls MiniCap Extended Life PD Transfer Sets with Twist Clamp (Part 5C4482) used in peritoneal dialysis due to potential PCB exposure risks. Affected units include all lots manufactured after H19I2:6088.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0373-2025Medical device Baxter ›

Lower-risk recall

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Contact the company

Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625

✎ GovInfoNow plain-language explainer

Baxter is recalling MiniCap Extended Life PD Transfer Sets with Twist Clamp (Part 5C4482) used in peritoneal dialysis because they may expose users to PCBs. This recall is due to potential exposure to non-dioxin-like PCBs during dialysis procedures. Read more at govinfonow.com/recall/53665-baxter-minicap-pd-transfer-set-recall-pcb-exposure-risk-in.

Source Summary by GovInfoNow · govinfonow.com/recall/53665-baxter-minicap-pd-transfer-set-recall-pcb-exposure-risk-in · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0373-2025

Cite this page

“Baxter MiniCap PD Transfer Set Recall: PCB Exposure Risk in Peritoneal Dialysis.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/53665-baxter-minicap-pd-transfer-set-recall-pcb-exposure-risk-in. Based on FDA recall #Z-0373-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0373-2025%22&limit=1).

Baxter Healthcare Corporation is voluntarily recalling its MiniCap Extended Life PD Transfer Set with Twist Clamp due to the potential risk of exposure to non-dioxin-like polychlorinated biphenyl acids and polychlorinated biphenyls. The Food and Drug Administration announced the Class I recall on October 21, 2024.

How to tell if you have it

Brand: Baxter
Product: MiniCap Extended Life PD Transfer Set with Twist Clamp
Part Number: 5C4482
UDI/DI: 00085412007731
Lot Codes: All lots manufactured after H19I26088

The hazard

Baxter is aware of several 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. According to FDA's MAUDE device-report database, there have been 40 reports naming the MiniCap Extended Life product since October 2023, including seven marked as serious and one listing a death.

Context

GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since September 2, 2015. Recent Baxter recalls include the August 18, 2026 PRO+ 40" MRS SURFACE Mattress Recall for incorrect labeling risk and the August 17, 2026 recalls of 0.9% Sodium Chloride Injection and Dextrose 2000mL Bags for fiberglass and stainless steel particulate risks. Other recent recalls of similar products include the Nipro MedicaLyte Bicarbonate Concentrate Recall (August 5, 2026) and the MedicaLyte Bicarbonate Powder Recall (August 5, 2026), both involving high endotoxin risk.

How to tell if you have this one

Check for the part number 5C4482 on the device. The product was sold with UDI/DI 00085412007731 and manufactured after H19I26088.

Brand
Baxter
Category
Medical device

FDA recall event · 10 products

All 10 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
Worldwide Distribution (US Nationwide distribution)

Recall number	Product, codes & lots	Quantity
Z-0373-2025	Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis; UDI/DI 00085412007731, Lot/Serial Numbers: All lots including and manufactured after H19I26088	2,706,558 units
Z-0374-2025	Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis; UDI/DI 00085412489643, Lot/Serial Numbers: All lots including and manufactured after H20A30068	56,304 units
Z-0375-2025	Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis; UDI/DI 00085412476261, Lot/Serial Numbers: All lots including and manufactured after H19J11055	151,020 units
Z-0376-2025	Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis; UDI/DI 00085412007748, Lot/Serial Numbers: All lots manufactured between and including H19J14422 and H24F17045	319,308 units
Z-0377-2025	Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis; UDI/DI 00085412007748, Lot/Serial Numbers: All lots including and manufactured after H19J22078	410,862 units
Z-0378-2025	Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis; UDI/DI 05413760375861, Lot/Serial Numbers: All lots including and manufactured after H19K04041	58,680 units
Z-0379-2025	Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis; UDI/DI 00085412008783, Lot/Serial Numbers: All lots including and manufactured after H19J21062	62,394 units
Z-0380-2025	Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis; UDI/DI 00085412050768, Lot/Serial Numbers: All lots including and manufactured after H20B11116	18,426 units
Z-0381-2025	Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis; UDI/DI 04987456422890, Lot/Serial Numbers: All lots including and manufactured after H20F09053	4,380 units
Z-0382-2025	Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis; UDI/DI 00085412008783, Lot/Serial Numbers: All lots including and manufactured after H20B11074	1,240 units

Based on the official FDA remedy

What to do — step by step

Check Device Details
Look for part number 5C4482 and UDI/DI 00085412007731 on the device label.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide Distribution (US Nationwide distribution)” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 37 days after the firm started it.

Oct 21, 2024Firm started the recall
Nov 20, 2024FDA classified it Class I
Nov 27, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53665-baxter-minicap-pd-transfer-set-recall-pcb-exposure-risk-in">Baxter MiniCap PD Transfer Set Recall: PCB Exposure Risk in Peritoneal Dialysis (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0373-2025 (October 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0373-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.