Urgent Voluntary Recall: Level 1 Fast Flow Fluid Warming System, NORMOFLO Fluid Warmer and Level 1 Normothermic I.V. Fluid Administration Set

Date: 09/15/2021

Product type:  Null

DATE NOTIFICATION INITIATED:

August 18, 2021

PRODUCT / LOT NUMBER:

Level 1® Fluid Warmer
Model Numbers: H-1000, H-500

Level 1® Fluid Warming System
Model Numbers: H-1028, H-1200

NORMOFLO® Fluid Warmer
Model Number: H-1025

Level 1® Normothermic I.V. Fluid Administration Set
Model Numbers: D-100, D-300, D-50, D-60HL, D-70, DI-100, DI-300, DI-50, DI-60HL, DI-70

MANUFACTURER:

Smiths Medical ASD Inc.
Minneapolis, MN

US-FDA Link: https://www.fda.gov/vaccines-blood-biologics/recalls-biologics/urgent-voluntary-recall-level-1-fast-flow-fluid-warming-system-normoflo-fluid-warmer-and-level-1