Recall Z-0030-2020 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Corporation
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
| Date | Oct 10, 2018 |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 8640 eaches |
| Distribution | U.S.: VA, DC, CA, FL, SC, MD, DE, PA, NC, WA, GA, TX, NV. No foreign (OUS) distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102936 | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R Baxter Healthcare Corp, Mar 30, 2011 |