Baxter Healthcare Corporation: Medical Device Recall in 2019 - (Recall #: Z-0030-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 10, 2018

Date Posted: October 9, 2019

Recall Number: Z-0030-2020

Event ID: 83191

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.

Status: Terminated

Product Quantity: 8640 eaches

Code Information:

Lot Number H18D22030

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated