The Recall Desk
HighFDA (Devices)·Z-0573-2022·Announced 2022-02-16

Baxter PD Transfer Sets may leak or crack from common cleaning products

Certain cleaning products can damage Baxter MiniCap Extended Life PD Transfer Sets, causing them to leak or crack. Baxter is recalling approximately 61,290 units sold 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: FDA Class II recall of a medical device critical for dialysis patients. While no illnesses have been reported, the documented vulnerability to common cleaning chemicals poses a risk to treatment effectiveness.

Plain-English summary

Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (model 5C4482EJ) after discovering that certain cleaning products can damage the device, causing it to leak or crack.

The affected transfer sets are used in peritoneal dialysis (PD), a kidney-replacement treatment. The recall involves all lot numbers within expiry, with approximately 61,290 units distributed worldwide.

Cleaning products containing hydrogen peroxide, bleach, alcohol, antiseptic agents, or certain solvents (such as acetone, toluene, xylene, or cyclohexanone) may cause damage to these transfer sets. Patients and healthcare facilities should not use affected sets with these cleaning products. If you have affected transfer sets, contact Baxter Healthcare Corporation for replacement or guidance.

The recalled product

Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
Manufacturer
Baxter Healthcare Corporation
Hazard
  • leaking
  • 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.