Baxter Dialysis Transfer Set Recalled for Connector Separation
Baxter Healthcare is recalling its MiniCap Extended Life PD Transfer Set (Part Number T5C4325K) due to increased complaints about the female connector separating from the main body of the device.
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 Class II medical device recall involves a mechanical failure (connector separation) in peritoneal dialysis equipment. The source reports increased complaints but documents no reported injuries or illnesses. As a risk-of-harm product that could interrupt critical dialysis treatment, this warrants a High severity rating.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K. This medical device is used in peritoneal dialysis for treatment of kidney failure. The recall involves 1,536 units with Lot/Serial Number H24E15066 distributed worldwide.
The recall was initiated due to an increase in complaints about the female connector separating from the main body of the transfer set. Patients using this device should consult with their healthcare provider regarding this recall.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1,536
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 (2)
- UDI/DI 0085412150710
- Lot/Serial Numbers: H24E15066
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.
See all 11 products in this recall →Related recalls
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Same hazard · connector separation
See all →- HighBaxter MiniCap Peritoneal Dialysis Sets Recalled for Connector Separation
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- HighBaxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall
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- HighBaxter MiniCap Extended Life PD Transfer Set Connector Separation Complaints
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- HighBaxter MiniCap PD Transfer Set Recalled for Female Connector Separation
FDA (Devices) · 2024-12-04
- HighBaxter Peritoneal Dialysis Transfer Set Connector Separation Recall
FDA (Devices) · 2024-12-04
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