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

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

REASON:

Smiths Medical ASD Inc., the manufacturer of record for Level 1® Fast Flow Fluid Warming System, NORMOFLO® Fluid Warmer and Level 1® Normothermic I.V. Fluid Administration Set, is voluntarily recalling certain models of these devices. This recall is being performed out of an abundance of caution due to the potential for aluminum ions leaching into certain intravenous solutions and blood products prior to transfusion/infusion to a patient. Exposure to toxic levels of aluminum could potentially lead to serious injury or possibly death, depending on the treatment being administered and the patient’s condition.  

Smiths Medical issued an Urgent Medical Device Recall Notice Letter on August 18, 2021. This notice instructs customer and distributors to identify products within their possession, acknowledge understanding of the recall notice, complete and return the enclosed Recall Notice Response Form. Adverse events or quality problems experienced with the use of these devices must be reported to Smiths Medical via globalcomplaints@smiths-medical.com. Questions regarding this recall may be forwarded to fieldactions@smiths-medical.com. 

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The information in this listing reflects CBER’s best efforts to communicate information that has been reported to FDA.  Its accuracy and comprehensiveness cannot be guaranteed.