—#173968

Product

L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

FDA product code: FKX — System, Peritoneal, Automatic Delivery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K102936
Affected lot / code info: Lot Number H18D22030

Why it was recalled

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.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: U.S.: VA, DC, CA, FL, SC, MD, DE, PA, NC, WA, GA, TX, NV. No foreign (OUS) distribution.

Timeline

Recall initiated: 2018-10-10
Terminated: 2020-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173968. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.