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Open, Classified

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis

FDA Recall Z-0561-2025 · Posted 2024-11-27

Recall StatusOpen, Classified
Product CodeKDJ
Date Initiated2024-10-23
Product Quantity31248 units

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.

Firm Action

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

Distribution Pattern

Worldwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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