FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
- Recall number
- Z-0563-2025
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
- Status
- Open, Classified
- Initiated
- 2024-10-23
- Posted
- 2024-11-27
- Terminated
- not on file
- 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.
- 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
- 83,448 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- UDI/DI 00085412007748, Lot/Serial Numbers: H23K15033, H23K17088, H23L15049, H23L20049, H24A17046, H24A23069, H24C13090, H24D15036, H24C29493
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDJ
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28