Baxter Peritoneal Dialysis Transfer Set Connector Separation Recall
Baxter is recalling 83,448 units of MiniCap Extended Life PD Transfer Sets due to reports of female connector separation from the device body.
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. No hospitalizations, illnesses, or injuries explicitly reported in the source. The connector separation is a functional defect in a critical dialysis device that poses a risk of improper device operation, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling approximately 83,448 units of the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number R5C4482) distributed worldwide. The recall was initiated due to an increase in complaints regarding separation of the female connector from the main body of the transfer set.
The transfer set is a medical device used in peritoneal dialysis treatment. Separation of the female connector from the transfer set body could prevent the device from functioning properly and affect the delivery of dialysis treatment.
Patients and healthcare providers using affected units should contact Baxter Healthcare Corporation or their dialysis care team for guidance. Affected lot numbers are H23K15033, H23K17088, H23L15049, H23L20049, H24A17046, H24A23069, H24C13090, H24D15036, and H24C29493.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 83,448
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: H23K15033
- H23K17088
- H23L15049
- H23L20049
- H24A17046
- H24A23069
- H24C13090
- H24D15036
- H24C29493
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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