Baxter MiniCap PD Transfer Sets may leak or crack with certain cleaners
Certain cleaning products can damage Baxter MiniCap PD Transfer Sets, potentially causing them to leak or crack. This could affect the safety of peritoneal dialysis treatment if the damaged set is used.
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 is classified as High because the product is a medical device with potential risk of harm (leaking or cracking) that could affect dialysis treatment safety, though no illnesses or injuries have been reported. The FDA Class II classification supports this assessment.
Plain-English summary
Baxter Healthcare Corporation is recalling 13,590 units of the Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long (REF R5C4484) worldwide. This is a medical device used in peritoneal dialysis, a kidney failure treatment.
The transfer sets may leak or crack if exposed to certain cleaning products, including hydrogen peroxide, bleach, alcohol, antiseptic agents, and solvents such as acetone, toluene, xylene, or cyclohexanone. These are common household and healthcare cleaning products.
Patients and healthcare facilities using these transfer sets should avoid exposure to these cleaning agents. If exposure has occurred, consult your healthcare provider immediately. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 13,590
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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