Baxter MiniCap Peritoneal Dialysis Transfer Set Recalled for Chemical Exposure Risk
Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to polychlorinated biphenyls found in similar devices.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number 5C4482EJ). This product is used for peritoneal dialysis. The recall affects 56,304 units distributed worldwide, including nationwide distribution in the United States.
The recall is being conducted because 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). These chemicals have been identified as a potential risk when using certain peritoneal and hemodialysis devices.
The affected units include all lots manufactured after H20A30068. The Unique Device Identifier (UDI/DI) is 00085412489643. Patients and healthcare providers should consult the FDA recall notice for specific instructions on how to proceed with the use of these devices.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 56,304
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00085412489643
- Lot/Serial Numbers: All lots including and manufactured after H20A30068
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
Same hazard · chemical exposure
See all →- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Similar recalls
- HighBaxter MiniCap PD Transfer Sets Recalled for Chemical Damage Risk
FDA (Devices) · 2022-02-16
- HighBaxter Peritoneal Dialysis Transfer Set Recalled for Connector Separation
FDA (Devices) · 2024-12-04
- HighBaxter Peritoneal Dialysis Transfer Set Connector Separation Recall
FDA (Devices) · 2024-12-04
- ModerateBaxter Recalls MiniCap Peritoneal Dialysis Transfer Sets for Labeling Updates
FDA (Devices) · 2015-09-02
- HighBaxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall
FDA (Devices) · 2024-12-04
- HighBaxter MiniCap Peritoneal Dialysis Sets Recalled for Connector Separation
FDA (Devices) · 2024-12-04