Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis

FDA device recall Z-0567-2025 · posted 2024-11-27 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

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.

Action taken

Baxter issued a SAFETY ALERT notice to its consignees on 10/23/2024 via USPS first class mail. The notice explains the issue and potential hazard involved. The notice addressed to dialysis providers indicated that if a patient contacts your clinic experiencing separation of the transfer set, to replace their transfer set and contact Baxter. Notices addressed to peritoneal patients provided the following instructions: "If you experience a separation of the transfer set, please close the transfer set twist clamp and do not cut the patient line. Contact your doctor and/or nurse immediately to arrange for a transfer set replacement and further guidance." Distributors were directed to notify their customers. For general questions regarding this communication, please contact Baxter Renal Home Care Services which can be reached at 800-284-4060, option 1, between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KDJ

Quantity affected

1496 units

Distribution

Worldwide distribution.

Date initiated

2024-10-23

Date posted

2024-11-27

Location

Deerfield, IL