Z-0561-2025Class II

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

Name: Z-0561-2025 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Creator: Baxter Healthcare Corporation
Published: 2024-10-23
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-10-23 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis on 2024-10-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0561-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-23
Posted: 2024-11-27
Recalling firm: Baxter Healthcare Corporation
Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Product code: KDJ Set, Administration, For Peritoneal Dialysis, Disposable
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 31248 units
Distribution: Worldwide distribution.
Product codes and lots: UDI/DI 00085412476261, Lot/Serial Numbers: H23J13063, H23J26081, H24B18059, H24B19065, H24B19099, H24B20071, H24C18065, H24E22062, H24F11048

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0561-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0559-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27
Z-0560-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27
Z-0561-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27
Z-0562-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27
Z-0563-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27
Z-0564-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27
Z-0565-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27
Z-0566-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27
Z-0567-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27
Z-0568-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27
Z-0569-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27

Product code KDJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)