Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
Reported: February 7, 2018 Initiated: July 27, 2017 #Z-0485-2018
Product Description
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
Reason for Recall
A leak may allow for microbial contamination of the sterile fluid path.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 29,088 units
- Distribution
- Distribution in the US and Canada.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.. Recalled by Baxter Healthcare Corporation. Units affected: 29,088 units.
Why was this product recalled? ▼
A leak may allow for microbial contamination of the sterile fluid path.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 7, 2018. Severity: Moderate. Recall number: Z-0485-2018.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11