Z-0030-2020 Class II Terminated
FDA device recall Z-0030-2020 was initiated by Baxter Healthcare Corporation on Oct 10, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jul 22, 2020). Affected quantity: 8640 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 9, 2019
- Initiation Date
- Oct 10, 2018
- Termination Date
- Jul 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8640 eaches
Product Description
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
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.
Distribution Pattern
U.S.: VA, DC, CA, FL, SC, MD, DE, PA, NC, WA, GA, TX, NV. No foreign (OUS) distribution.
Code Information
Lot Number H18D22030
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0030-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026