The Recall Desk
HighFDA (Devices)·Z-0570-2022·Announced 2022-02-16

Baxter peritoneal dialysis transfer sets may crack or leak with certain cleaners

Baxter MiniCap Extended Life PD Transfer Sets may be damaged by certain cleaning products containing hydrogen peroxide, bleach, alcohol, or solvents, potentially causing leaking or cracking. No injuries have been reported.

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 device recall with no reported illnesses or injuries. The hazard is theoretical: cleaning products may cause the peritoneal dialysis transfer set to crack or leak. The product poses risk of harm if damaged, but no actual injuries have been reported, placing this in the 'High' category per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corporation is recalling 23,940 units of the MiniCap Extended Life PD Transfer Set (Easy-Lock), model 5C4449, a medical device used in peritoneal dialysis. The recall affects all lot numbers within expiry and has been distributed worldwide.

Certain cleaning products can damage the transfer sets, specifically causing cracking or leaking. These include products containing hydrogen peroxide, bleach, alcohol, antiseptic agents, and solvents such as acetone, toluene, xylene, or cyclohexanone.

No illnesses or injuries have been reported to date. If you are using one of these affected transfer sets, contact your healthcare provider or Baxter Healthcare Corporation for guidance on replacement options or safe use.

The recalled product

Product
Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Dialysis Equipment
Hazard
  • device-damage
  • leaking
  • cracking
  • chemical-incompatibility

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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