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MiniCap recallZ-0373-2025 · Baxter Healthcare Corporation · initiated Oct 21, 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

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Baxter issued an "Important Medical Device Correction" notice to consignees beginning on 10/21/2024 via letter. In February 2025, Baxter Kidney Care segment launched a standalone company, Vantive. Vantive issued an updated notice to consignees beginning on 2/19/25 via letter. The notice explained the issue, hazard involved, and requested the following actions be taken: For patients older than 6 months of age, healthcare providers are advised to continue using both the peroxide-cured silicone tubing version and/or the platinum-cured silicone tubing version of the MiniCap Extended Life PD transfer sets, as neither is anticipated to present safety risks related to PCB/PCBAs. 2. For patients younger than 6 months: a. Healthcare providers should prioritize the use of platinum-cured silicone tubing sets or other alternatives that may be available. b. If no alternatives are available, healthcare providers should continue to connect the peroxide-cured silicone tubing sets and prioritize the use of shorter transfer sets. c. If the patient currently has the peroxide-cured silicone tubing, they do not need to have it replaced early, as data demonstrates that PCBA levels decrease over treatment time. 3. If you received this communication directly from Vantive, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. 4. If you purchased this product from a distributor, please note that responding via the Vantive customer portal is not applicable. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers.

Recall details

Recall number
Z-0373-2025
Status
Open, Classified
Initiated by the company
Oct 21, 2024
Posted by the FDA
Nov 20, 2024
Recalling firm
Baxter Healthcare Corporation
Quantity
2,706,558 units
Product code
KDJ
FDA submissions
K152675
Distribution
Worldwide Distribution (US Nationwide 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: All lots including and manufactured after H19I26088

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 95525).

Sources and updates

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