Baxter PD Transfer Set Recall: Risk of Leaking or Cracking
Baxter recalls 62,712 MiniCap Extended Life PD Transfer Sets worldwide due to potential damage from certain cleaning products. Exposure to products containing bleach, hydrogen peroxide, or solvents may cause leaking or cracking.
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: FDA Class II medical device with potential for serious harm if materials are damaged, classified as a risk-of-harm product where injury has not yet been reported. No reported illnesses or injuries; the hazard is conditional on exposure to specific cleaning products.
Plain-English summary
Baxter Healthcare Corporation is recalling 62,712 units of the MiniCap Extended Life PD Transfer Set with Twist Clamp (REF R5C4482E) distributed worldwide. The recall was initiated because certain cleaning products may damage the transfer sets. Specifically, 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.
All lot numbers within their expiry dates are included in the recall.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 62,712
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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