Baxter MiniCap Peritoneal Dialysis Sets Recalled for Connector Separation
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to increasing reports of the female connector separating from the main body. The defect affects 62,718 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 a Class II medical device recall with a confirmed structural defect (connector separation), but no reported illnesses, injuries, or deaths. Per the severity rubric, this qualifies as 'High' because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number 5C4483), used in peritoneal dialysis. The recall affects 62,718 units distributed worldwide.
The company has identified an increase in complaints regarding the separation of the female connector from the main body of the transfer set. Affected units are identified by UDI/DI number 00085412007748 and include the following lot/serial numbers: H23J10051, H23J23062, H23K20066, H24C08033, H24E16080, H24F12046, H24F17045, H24G02045, and H24I02090.
The defect involves mechanical failure of the connector assembly. The recall was issued by the U.S. Food and Drug Administration under recall number Z-0562-2025.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 62,718
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 (10)
- UDI/DI 00085412007748
- Lot/Serial Numbers: H23J10051
- H23J23062
- H23K20066
- H24C08033
- H24E16080
- H24F12046
- H24F17045
- H24G02045
- H24I02090
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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