Baxter CAPD Transfer Sets may crack or leak when exposed to cleaning chemicals
Baxter CAPD MiniCap Transfer Set II units may leak or crack when cleaned with chemicals including bleach, hydrogen peroxide, or solvents. The recall affects 8,928 units distributed 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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves potential chemical damage that could cause leaking or cracking of a medical device, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling the CAPD MiniCap Transfer Set II (24cm, Code No. T5C4482) because cleaning products may cause damage to the transfer sets.
Cleaning products containing hydrogen peroxide, bleach, alcohol, or solvent agents such as acetone, toluene, xylene, or cyclohexanone may cause the transfer sets to leak or crack. Approximately 8,928 units have been distributed worldwide. All lot numbers within expiry are affected.
Users of these transfer sets should avoid cleaning them with the chemicals listed above. Contact Baxter Healthcare Corporation or the FDA if you have questions or need to report any adverse events.
The recalled product
- Product
- Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 8,928
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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