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.
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: 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
- Affected units
- 61,290
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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