Baxter Healthcare: Empty IntraVia 500mL Containers Risk Microbial Contamination
Baxter Healthcare recalls empty 50:00mL IntraVia containers with non-DEHP fluid paths due to potential microbial contamination from leaks. Affected units have product code 2J8003 and lot number DR16J18096.
Lower-risk recall
A leak may allow for microbial contamination of the sterile fluid path.
Contact the company
What happened, in plain English
Baxter Healthcare is recalling empty 500mL IntraVia containers with non-DEHP fluid paths because leaks could allow microbial contamination of the sterile fluid path. This poses a risk to patients receiving drug treatments using these containers. Read more at govinfonow.com/recall/73340-baxter-healthcare-empty-intravia-500ml-containers-risk-microbial-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/73340-baxter-healthcare-empty-intravia-500ml-containers-risk-microbial-contamination · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0485-2018
Cite this page
“Baxter Healthcare: Empty IntraVia 500mL Containers Risk Microbial Contamination.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73340-baxter-healthcare-empty-intravia-500ml-containers-risk-microbial-contamination. Based on FDA recall #Z-0485-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0485-2018%22&limit=1).
Why it’s dangerous
Leaking containers could allow bacteria or other microbes to enter the sterile fluid path. This contamination could lead to infections in patients receiving drug treatments prepared using these containers.
Who’s affected
Healthcare facilities and patients using these containers for drug preparation and administration are most at risk. The recall affects specific units with product code 2J8003 and lot number DR16J18096.
How to tell if you have this one
Check for product code 2J8003 and lot number DR16J18096 on the container. These empty 500mL IntraVia containers with non-DEHP fluid paths are used for preparing drug solutions.
- Brand
Baxter Healthcare- Category
Medical device
What to do — step by step
Check Container Details
Look for product code 2J8003 and lot number DR16J18096 on the container.
How this recall unfolded
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0485-2018 (July 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0485-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.