Class 2 Device Recall HomeChoice L5C4531 X1Integrated APD Set with Cassette 3Prong

• Date Initiated by Firm: October 10, 2018
• Create Date: October 03, 2019
• Recall Status: Terminated on July 22, 2020
• Recall Number: Z-0030-2020
• Recall Event ID: 83191
• 510(K)Number: K102936
• Product Classification: System, peritoneal, automatic delivery - Product Code FKX
• Product: L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
• Code Information: Lot Number H18D22030
• FEI Number: 1417572
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• Manufacturer Reason for Recall: Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile fluid path with micro-organisms. This may predispose the patient to peritonitis.
• FDA Determined Cause: Mixed-up of materials/components
• Action: On 10/10/2018, and 10/15/2018, Urgent Product Recall notices were mailed to dialysis providers at medical centers. Customers were asked to do the following: 1. Locate and remove the affected product lot from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact recalling firm for Service to arrange for return and credit. Center for Service can be reached at 888-229-0001. 3. If you purchased this product directly from the recalling firm, complete and return the enclosed customer reply form. 4. If you purchased this product from a distributor, please contact your distributor for return and credit. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 5. If you distribute 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 conduct a consumer-level recall of the affected product that you distributed to customers. Customers with additional questions are encouraged to contact: Corporate Product Surveillance at 800-437-5176, Clinical Helpline at 888-736-2543, and Renal Therapy Services at 800-553-6898. On 10/15/2018, Urgent Product Recall notices were mailed to Peritoneal Dialysis Patients who were asked to do the following: 1. Locate and remove the affected product lot from your supplies. The product code and lot number can be found on the individual product or shipping carton. 2. Contact recalling firm to arrange for return and credit. HomeCare Services can be reached at 800-284-4060. 3. Complete and return the enclosed Home Patient Reply Form.
• Quantity in Commerce: 8640 eaches
• Distribution: U.S.: VA, DC, CA, FL, SC, MD, DE, PA, NC, WA, GA, TX, NV. No foreign (OUS) 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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