Z-0380-2025Class I

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis

Name: Z-0380-2025 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
Creator: Baxter Healthcare Corporation
Published: 2024-10-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-10-21 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis on 2024-10-21. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0380-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-10-21
Posted: 2024-11-20
Recalling firm: Baxter Healthcare Corporation
Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
Product code: KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 18,426 units
Distribution: Worldwide Distribution (US Nationwide distribution)
Product codes and lots: UDI/DI 00085412050768, Lot/Serial Numbers: All lots including and manufactured after H20B11116

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0380-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0373-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20
Z-0374-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20
Z-0375-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20
Z-0376-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20
Z-0377-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20
Z-0378-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20
Z-0379-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20
Z-0380-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20
Z-0381-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20
Z-0382-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20

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)