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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 116,628
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.
Part of a larger recall action
This product is one of 11 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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