FDA Device recall Z-0485-2018
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admi…
- FDA Device
- Class II
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class II recall of Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admi… by Baxter Healthcare, citing A leak may allow for microbial contamination of the sterile fluid path.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0485-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-27 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
Product
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
Reason
A leak may allow for microbial contamination of the sterile fluid path.
Identifiers
| code_info | Product Code 2J8003, Lot No. DR16J18096. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0485-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.