Recall Z-0566-2025— Baxter Healthcare Corporation

Name: FDA recall Z-0566-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-23

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-10-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis. Reason: There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-10-23
Firm location: Deerfield, IL, United States

Product description

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis

Reason for recall

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Data sourced from openFDA. This site is unofficial and independent of the FDA.