Baxter 2B8013 Empty INTRA VIA Container with PVC Ports — Class I medical device recall Z-0085-2015
Terminated recall by Baxter Healthcare Corp, reported 2014-11-12, distributed nationwide. Particulate matter found inside the fluid path.
| Recall number | Z-0085-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp, Deerfield, IL, United States |
| Recall initiated | 2014-09-16 |
| Classified | 2014-10-31 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2017-06-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 20,448 |
| Reason classes | specification failure |
| Lot numbers | UR13K14095 |
Product
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
Reason for recall
Particulate matter found inside the 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-0085-2015. 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.