EXACTAMIX Empty EVA Bags — Class II medical device recall Z-0365-2019
Terminated recall by Baxter Healthcare Corporation, reported 2018-11-07, distributed nationwide. Potential ability to leak once used for compounding.
| Recall number | Z-0365-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2018-09-12 |
| Classified | 2018-11-01 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2020-11-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CN, HK, NZ, UY |
| Quantity | 136,800 units |
| Reason classes | packaging |
| Lot numbers | 60066021, 60069101, 60070846, 60072119, 60075857, 60080377, 60081688, 60084632, 60095474, 60097844, 60098902, 60110761, 60110765, 60120570, 60124005, 60124006, 60124008, 60126009 |
Product
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Reason for recall
Potential ability to leak once used for compounding.
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-0365-2019. 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.