L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile — Class II medical device recall Z-0030-2020
Terminated recall by Baxter Healthcare Corporation, reported 2019-10-09, distributed in CA, DC, DE, FL, GA, MD, NC, NV…. Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting
| Recall number | Z-0030-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2018-10-10 |
| Classified | 2019-10-03 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2020-07-22 |
| Distributed | CA, DC, DE, FL, GA, MD, NC, NV, PA, SC, TX, VA, WA |
| Quantity | 8,640 eaches |
| Reason classes | sterility, packaging |
| Lot numbers | H18D22030 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0030-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.