Z-0030-2020Class II

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

Name: Z-0030-2020 L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene...
Creator: Baxter Healthcare Corporation
Published: 2018-10-10
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2018-10-10 / Terminated / root cause: sterility

FDA source

Baxter Healthcare Corporation began a recall of L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide on 2018-10-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0030-2020
Classification: Class II
Status: Terminated
Initiated: 2018-10-10
Posted: 2019-10-03
Terminated: 2020-07-22
Recalling firm: Baxter Healthcare Corporation
Product: L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Product code: FKX System, Peritoneal, Automatic Delivery
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.
Root cause tag: sterility
FDA 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 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.
Product codes and lots: Lot Number H18D22030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0030-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0030-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-03

Product code FKX

K102936Class IIHomechoice/homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model 5C4471, 5C8310, 5C4471r and 5C8310rBaxter Healthcare Corp / cleared 2011-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)