Baxter MiniCap PD Transfer Set Recall—Damage from Cleaning Products
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets worldwide because cleaning products containing hydrogen peroxide, bleach, alcohol, or solvents may cause the devices 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 recall of a medical device used in life-sustaining peritoneal dialysis treatment. No illnesses or injuries are reported in the source. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in a High (3) severity score.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (REF R5C4482) worldwide. The recall affects 449,676 units across all lot numbers that remain within their expiration dates.
Cleaning products containing hydrogen peroxide, bleach, alcohol, antiseptic agents, or solvents such as acetone, toluene, xylene, or cyclohexanone may damage the transfer sets, causing leaking or cracking. This is an FDA Class II recall.
If you are using this product, avoid exposure to the identified cleaning products. Patients and healthcare providers with questions should contact Baxter Healthcare Corporation. The product's reference number is REF R5C4482.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 449,676
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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