The Recall Desk
HighFDA (Devices)·Z-0577-2022·Announced 2022-02-16

Baxter PD Transfer Sets Recalled Due to Chemical Damage Risk

Baxter Healthcare is recalling approximately 58,194 units of its MiniCap Extended Life PD Transfer Sets distributed worldwide because certain cleaning products may damage the sets, causing leaking or cracking.

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 FDA medical device recall meets the high-severity criterion for risk-of-harm products where injury has not yet been reported. The hazard—chemical damage causing leaks or cracks—poses potential risk to the functionality of the transfer set.

Plain-English summary

Baxter Healthcare Corporation is recalling approximately 58,194 units of the Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short (REF R5C4483) distributed worldwide.

The recall was initiated because cleaning products containing hydrogen peroxide, bleach, alcohol, antiseptic agents, or solvents such as acetone, toluene, xylene, or cyclohexanone may damage the transfer sets, causing them to leak or crack.

All lot numbers of the affected product within expiry are included in this recall.

The recalled product

Product
Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Dialysis Equipment
Hazard
  • leaking
  • cracking
  • chemical-exposure

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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