Baxter MiniCap PD Transfer Set (Baxter) – Chemical Risk (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
UDI/DI 00085412007731, Lot/Serial Numbers: All lots including and manufactured after H19I26088
Products Sold
UDI/DI 00085412007731, Lot/Serial Numbers: All lots including and manufactured after H19I26088
Baxter Healthcare Corporation is recalling Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritonea due to Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026