Empty IntraVia Container with Non-DEHP Fluid Path — Class II medical device recall Z-0485-2018
Terminated recall by Baxter Healthcare Corporation, reported 2018-02-07. A leak may allow for microbial contamination of the sterile fluid path.
| Recall number | Z-0485-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2017-07-27 |
| Classified | 2018-01-29 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2020-11-03 |
| Countries outside the US | CA |
| Quantity | 29,088 units |
| Reason classes | microbial contamination, sterility, packaging |
| Lot numbers | DR16J18096 |
Product
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
Reason for recall
A leak may allow for microbial contamination of the sterile fluid path.
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-0485-2018. 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.