The Recall Desk
HighFDA (Devices)·Z-0580-2022·Announced 2022-02-16

Baxter CAPD Transfer Sets May Leak if Cleaned with Certain Chemicals

Baxter Healthcare is recalling CAPD MiniCap Transfer Set II units worldwide because certain cleaning products containing chemicals like hydrogen peroxide, bleach, and solvents may cause the sets to leak or crack.

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 is a critical medical device (peritoneal dialysis equipment), and equipment failure could result in serious patient harm. The recall addresses a risk-of-harm product where no incidents have been reported, consistent with a High severity classification.

Plain-English summary

Baxter Healthcare Corporation is recalling the CAPD MiniCap Transfer Set II (34cm), Code No. T5C4484, a peritoneal dialysis transfer set. The recall affects 2,240 units distributed worldwide, including all lot numbers that are within their expiration date.

Cleaning products containing hydrogen peroxide, bleach, alcohol, antiseptic agents, or solvents such as acetone, toluene, xylene, or cyclohexanone may cause the transfer sets to leak or crack. Healthcare facilities and patients using this equipment should be aware of this chemical compatibility issue.

The recalled product

Product
Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Dialysis Equipment
Hazard
  • leaking
  • cracking
  • chemical-damage

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 (1)

  • All lot numbers within expiry

Distribution

Distribution scope not specified by the agency.

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