The Recall Desk
HighFDA (Devices)·Z-0574-2022·Announced 2022-02-16

Baxter Peritoneal Dialysis Transfer Sets Recalled for Chemical Damage Risk

Baxter is recalling 116,628 peritoneal dialysis transfer sets worldwide because certain cleaning chemicals can damage the device, potentially 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 FDA Class II recall involves a medical device with potential for significant harm—leaking or cracking of a peritoneal dialysis transfer set could compromise treatment. However, no illnesses or injuries have been reported in the source text, and the hazard only occurs with specific chemical exposures.

Plain-English summary

Baxter Healthcare Corporation is recalling 116,628 Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion transfer sets. These are peritoneal dialysis transfer sets distributed worldwide, with all lot numbers within the product's shelf life included in the recall.

Cleaning products containing hydrogen peroxide, bleach, alcohol, antiseptic agents, or solvents such as acetone, toluene, xylene, or cyclohexanone may cause damage to the transfer sets. This damage can manifest as leaking or cracking of the device.

Peritoneal dialysis patients using these transfer sets should be aware of this recall.

The recalled product

Product
Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Dialysis Equipment
Hazard
  • chemical-damage
  • 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.

Related recalls

Same category