Recall Z-0562-2025— Baxter Healthcare Corporation

Name: FDA recall Z-0562-2025
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. It names one FDA 510(k) clearance: K192705. Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; 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

510(k) clearances named in this recall

1 on FDA's record

K192705 — MiniCap Extended Life PD Transfer SetsBaxter Healthcare·cleared 2019-10-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; 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.