The Recall Desk
HighFDA (Devices)·Z-0568-2025·Announced 2024-12-04

Baxter Dialysis Transfer Set Recalled for Connector Separation

Baxter Healthcare is recalling its MiniCap Extended Life PD Transfer Set (Part Number T5C4325K) due to increased complaints about the female connector separating from the main body of the device.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II medical device recall involves a mechanical failure (connector separation) in peritoneal dialysis equipment. The source reports increased complaints but documents no reported injuries or illnesses. As a risk-of-harm product that could interrupt critical dialysis treatment, this warrants a High severity rating.

Plain-English summary

Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K. This medical device is used in peritoneal dialysis for treatment of kidney failure. The recall involves 1,536 units with Lot/Serial Number H24E15066 distributed worldwide.

The recall was initiated due to an increase in complaints about the female connector separating from the main body of the transfer set. Patients using this device should consult with their healthcare provider regarding this recall.

The recalled product

Product
Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Peritoneal Dialysis Equipment
Hazard
  • connector-separation
  • mechanical-failure

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 0085412150710
  • Lot/Serial Numbers: H24E15066

Distribution

Distribution scope not specified by the agency.

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