MARS Treatment Kit — Class II medical device recall Z-0411-2018
Terminated recall by Baxter Healthcare Corporation, reported 2018-01-31. Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an
| Recall number | Z-0411-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2017-12-21 |
| Classified | 2018-01-24 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2020-08-04 |
| Countries outside the US | BE, CN, DE, ES, FR, HK, IT, KR, MX, MY, PL, PT, RU, SE, TH, TR, TW |
| Quantity | 186 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 37332414107728 |
| Lot numbers | 0000022597, 0000022648, 0000022663, 0000022671, 0000022721, 0000022767 |
Product
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Reason for recall
Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set which is part of the MARS Treatment Kit.
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-0411-2018. 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.