The Recall Desk
HighFDA (Devices)·Z-0579-2022·Announced 2022-02-16

Baxter CAPD Transfer Sets may crack or leak when exposed to cleaning chemicals

Baxter CAPD MiniCap Transfer Set II units may leak or crack when cleaned with chemicals including bleach, hydrogen peroxide, or solvents. The recall affects 8,928 units distributed worldwide.

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 an FDA Class II recall with no reported illnesses or injuries. The hazard involves potential chemical damage that could cause leaking or cracking of a medical device, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corporation is recalling the CAPD MiniCap Transfer Set II (24cm, Code No. T5C4482) because cleaning products may cause damage to the transfer sets.

Cleaning products containing hydrogen peroxide, bleach, alcohol, or solvent agents such as acetone, toluene, xylene, or cyclohexanone may cause the transfer sets to leak or crack. Approximately 8,928 units have been distributed worldwide. All lot numbers within expiry are affected.

Users of these transfer sets should avoid cleaning them with the chemicals listed above. Contact Baxter Healthcare Corporation or the FDA if you have questions or need to report any adverse events.

The recalled product

Product
Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Dialysis / Transfer Set
Hazard
  • chemical-damage
  • leakage
  • cracking

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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