Baxter MiniCap PD Transfer Sets Recalled Due to Damage from Cleaning Products
Baxter Healthcare is recalling 344,190 units of MiniCap Extended Life PD Transfer Sets worldwide because certain cleaning products may cause the sets to leak or crack, potentially affecting patient dialysis treatment.
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 classification with potential product failure (leaking or cracking) of a critical medical device poses risk of harm. No actual illnesses or injuries have been reported; the hazard is theoretical based on exposure to certain cleaning chemicals.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Extra Short model, part number 5C4483) globally. The recall affects all lot numbers currently within their expiration dates, totaling approximately 344,190 units.
The transfer sets may be damaged—including leaking or cracking—when exposed to certain cleaning products. These products include those containing hydrogen peroxide, bleach, alcohol, antiseptic agents, or organic solvents such as acetone, toluene, xylene, or cyclohexanone.
Patients using these transfer sets for peritoneal dialysis should avoid cleaning them with products containing these chemicals. If damage occurs, the transfer set should not be used and should be replaced. Patients with questions should contact Baxter Healthcare or their healthcare provider.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 344,190
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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