Class 2 Device Recall MiniCap Disconnect Caps

• Date Initiated by Firm: February 01, 2023
• Date Posted: March 03, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1213-2023
• Recall Event ID: 91612
• 510(K)Number: K152129
• Product Classification: Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
• Product: Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
• Code Information: UDI/DI 00085412007694, Lot numbers: GD912051, exp 31-Mar-2024; GD912068, exp 30-Apr-2024; GD912099, exp 30-Apr-2024; GD912112, exp 30-Apr-2024; GD912143, exp 30-Apr-2024; GD912204, exp 31-May-2024. Expansion on 05/10/2023: Product Code 5C4466P with all lots numbers manufactured prior to 09/30/2022.
• 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: MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant.
• FDA Determined Cause: Process control
• Action: Baxter Healthcare initiated the recall by issuing an Urgent Medical Device Recall notice to its consignees by letter on 02/01/2023. The notice requested the following from customers: 1. Check your stock and set aside all product with the affected lot numbers. 2. Contact Baxter HomeCare Services to arrange for return of impacted product and for ordering replacement product. 3. If all of your product is impacted by this recall and you are unable to get unaffected lot numbers, resulting in a significant delay in therapy, please follow the below steps: a. Contact your clinic for clinical guidance and check each pouch and do not use the MiniCap contained inside of any pouches that appear to have damaged seals. For general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday." Recall was expanded and Baxter Healthcare sent an updated notification to customers and patients on 05/09/2023. The letter instructed consignees and patients to immediately cease use of the affected product, arrange for the return of affected product and assess each patient's individual next steps based on clinical evaluation. Customers were also instructed to complete the customer response form via the portal (for products directly received from Baxter) or through the distributor. If the products were further distributed, please notify customers.
• Quantity in Commerce: 33,866,400 units
• Distribution: US Nationwide distribution and Canada.
• 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 and Original Applicant = BAXTER HEALTHCARE CORPORATION