Skip to content

MiniCap recallZ-0559-2025 · Baxter Healthcare Corporation · initiated Oct 23, 2024

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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-0559-2025
Status
Open, Classified
Initiated by the company
Oct 23, 2024
Posted by the FDA
Nov 27, 2024
Recalling firm
Baxter Healthcare Corporation
Quantity
409464 units
Product code
KDJ
FDA submissions
K152675
Distribution
Worldwide distribution.

Product description

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis

Code information (models, lots, serial numbers)

UDI/DI 00085412007731, Lot/Serial Numbers: H23J16074, H23K01082, H23K06107, H23K09093, H23K28051, H23K30081, H23L07053, H23L13051, H23L27093, H24A03061, H24A09035, H24A11064, H24A29132, H24B02038, H24B12086, H24B21079, H24B28090, H24B29072, H24B29098, H24C21093, H24C27090, H24D08064, H24D11050, H24D17040, H24D22081, H24D26058, H24D30076, H24E06065, H24E23037, H24E28051, H24F03045, H24F05065, H24F17086, H24F24033, H24F27036, H24H05061, H24H08032, H24H13040, H24H16043, H24H22025

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K152675 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95524).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page