Database updated: 28 November 2022

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:29600
Brand Name:Smiths Medical ASD (MMSP) Fluid Warmer
Model:
Affected:Affective product - H-1000, H-1025, H-1200
Software version:
Recalling Organisation:Smiths Medical Australasia Pty Ltd
c/o KPMG, KPMG Centre
18 Viaduct Harbour Avenue
Auckland
Contact Information:0800 444 200
Manufacturer:Smiths Medical ASD Inc
Issue:The manufacturer implemented a design change to widen the hinge assembly on the Level 1 H-2 Pressure Chambers used with the Level 1 Fast Flow Fluid Warmers (Models H-1025 or H-1200) or added to the H-1000 model. The manufacturer has become aware that Level 1 H-2 Pressure Chambers with the wider hinge assembly can potentially impact the amount of pressure exerted onto the IV fluid bag while contained within the pressure chamber. This may result in decreased flow rate, stopped flow or residual fluid left within the IV bag.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:28/6/2022
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