Class 1 Device Recall Baxter MiniCap

• Date Initiated by Firm: October 21, 2024
• Date Posted: November 20, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0376-2025
• Recall Event ID: 95525
• 510(K)Number: K192705
• Product Classification: Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
• Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
• Code Information: UDI/DI 00085412007748, Lot/Serial Numbers: All lots manufactured between and including H19J14422 and H24F17045
• FEI Number: 1417572
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer 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.
• FDA Determined 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: 319,308 units
• Distribution: Worldwide Distribution (US Nationwide distribution)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KDJ