FDA Device recall Z-0085-2015
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml
- FDA Device
- Class I
- terminated
- Published 2014-11-12
On 2014-11-12 the FDA classified a Class I recall of Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml by Baxter Healthcare, citing particulate matter found inside the fluid path.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0085-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-09-16 |
| Published | 2014-11-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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
Particulate matter found inside the fluid path.
Identifiers
| code_info | Product code 2B8013 Lot Number: UR13K14095 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0085-2015%22
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