Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 admixtures.

U.S. FDA — Device Enforcement · United States · 2017-07-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0485-2018
Date of alert
2017-07-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Baxter Healthcare Corporation
Product category
device
Product type
Devices
Reported risk: A leak may allow for microbial contamination of the sterile fluid path.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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