Baxter Peritoneal Dialysis Transfer Set Recalled for Connector Separation
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to an increase in complaints of female connector separation from the transfer set body. Peritoneal dialysis patients should contact their healthcare provider.
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 with a reported increase in connector-separation complaints. No injuries, illnesses, or hospitalizations have been reported in the source text. Per the rubric, a risk-of-harm product where injury has not yet been reported scores 3 (High).
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number R5C4482E) for use in peritoneal dialysis treatment. The recall was announced due to an increase in complaints about the female connector separating from the main body of the transfer set.
Peritoneal dialysis patients who use this transfer set may be affected. The product has been distributed worldwide. The recall involves lot numbers H23J18054 and H24G10063 (UDI/DI 05413760375861), affecting approximately 13,608 units.
Patients using this transfer set should immediately contact their healthcare provider or Baxter Healthcare Corporation. Do not continue using the recalled product. Patients should follow guidance from their healthcare provider regarding treatment alternatives and the return of the recalled equipment.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 13,608
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 (3)
- UDI/DI 05413760375861
- Lot/Serial Numbers: H23J18054
- H24G10063
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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Same hazard · connector separation
See all →- HighBaxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall
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