MiniCap recallZ-0563-2025 · Baxter Healthcare Corporation · initiated Oct 23, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0563-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 23, 2024
- Posted by the FDA
- Nov 27, 2024
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 83,448 units
- Product code
- KDJ
- Distribution
- Worldwide distribution.
Product description
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Code information (models, lots, serial numbers)
UDI/DI 00085412007748, Lot/Serial Numbers: H23K15033, H23K17088, H23L15049, H23L20049, H24A17046, H24A23069, H24C13090, H24D15036, H24C29493
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MiniCap 5C4483Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE4 recalls433 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 95524).
- Z-0559-2025 · Open, ClassifiedBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
- Z-0562-2025 · Open, ClassifiedBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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