Baxter CAPD Transfer Sets May Leak if Cleaned with Certain Chemicals
Baxter Healthcare is recalling CAPD MiniCap Transfer Set II units worldwide because certain cleaning products containing chemicals like hydrogen peroxide, bleach, and solvents may cause the sets 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 a critical medical device (peritoneal dialysis equipment), and equipment failure could result in serious patient harm. The recall addresses a risk-of-harm product where no incidents have been reported, consistent with a High severity classification.
Plain-English summary
Baxter Healthcare Corporation is recalling the CAPD MiniCap Transfer Set II (34cm), Code No. T5C4484, a peritoneal dialysis transfer set. The recall affects 2,240 units distributed worldwide, including all lot numbers that are within their expiration date.
Cleaning products containing hydrogen peroxide, bleach, alcohol, antiseptic agents, or solvents such as acetone, toluene, xylene, or cyclohexanone may cause the transfer sets to leak or crack. Healthcare facilities and patients using this equipment should be aware of this chemical compatibility issue.
The recalled product
- Product
- Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 2,240
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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