Baxter MiniCap PD Transfer Sets Recalled for Chemical Damage Risk
Baxter Healthcare is recalling 2,553,528 units of the MiniCap Extended Life PD Transfer Set worldwide because cleaning products containing certain chemicals may cause the device to leak or crack.
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 an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is potential damage (leaking or cracking) to a critical dialysis device caused by exposure to certain cleaning chemicals. Since no actual harm has been reported and the risk is theoretical, the severity is classified as High.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (model 5C4482) worldwide. The recall affects all 2,553,528 units across all lot numbers within their expiration dates. The transfer set is a medical device used in peritoneal dialysis treatment.
The FDA has classified this as a Class II 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, resulting in leaking or cracking.
Patients and healthcare providers using these transfer sets should avoid using the listed cleaning products on or near the device. If you have this product or suspect it has been exposed to these chemicals, contact Baxter Healthcare Corporation or your healthcare provider for guidance. Do not use the device if it shows signs of damage such as cracks or leaks.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 2,553,528
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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