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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 005 08 22 000
Date submitted: 8/10/2022
Manufacturer:Smiths Medical International Limited
Device Type:Level 1® H-2 Pressure Chambers
Description:Fast Flow Fluid Warmer
Medical Device Identifier:Affected Product Name: Level 1® H-2 Pressure Chamber
Affected Models: 7204012
Serial Numbers: 44000173 to 44007145

Affected Product Name: Latch Assembly H-2 Plus
Affected Models:7203019
All Lot Numbers

Affected Product Name: Door Assembly H-2 Plus
Affected Models: 7203020
Serial Numbers / Lot Numbers: All Lot Numbers
Reason of Field Safety Corrective Action:Smiths Medical 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.
Remedy Action:Refer to “Required Actions for Users” in the attached FSN.

Smiths Medical will be providing a replacement kit and associated instructions to customers so they can modify any affected Level 1 H-2 Pressure Chambers with a narrower hinge assembly. Smiths Medical will contact customers when replacement kits are available
Athorized Representative/Importer/Distributor:almadar medical Est.
Report Source:NCMDR
Source Ref. Number:4B474E097615F
SFDA Comments:SFDA urges all healthcare providers that have devices subjected to this safety alert to contact the company.
Attachments: Smiths Medical International Limited.pdf