Hemodialysis Delivery System — Class II medical device recall Z-0215-2022
Ongoing recall by Baxter Healthcare Corporation, reported 2021-11-17, distributed nationwide. If the operator initiates therapy with a saved prescription profile and makes a change to the prescription aft
| Recall number | Z-0215-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2021-09-29 |
| Classified | 2021-11-11 |
| Reported by FDA | 2021-11-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, DE, DK, ES, FI, GB, GR, HK, IE, IL, IT, MX, NL, NO, PL, PT, SA, SE, SG, TR, VN |
| Quantity | 4,248 |
| UPC / GTIN / UDI-DI | 00085412639499, 07332414124359, 07332414124700, 07332414125844 |
| Serial numbers | 100121, 100134, 100185, 100210, 100214, 100268, 100269, 100271, 100273, 100274, 100275, 100276, 100278, 100279, 100300, 100302, 100303, 100305, 100316, 100319, 100320, 100331, 100332, 100333, 100335 and 475 more |
Product
Hemodialysis Delivery System, Software Version 2.x.
Reason for recall
If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.
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-0215-2022. 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.