SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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Reference Number:	mdprc 137 04 16 000
Date submitted:	4/28/2016

Manufacturer:	3M Health Care Ltd
Device Type:	3M Ranger High Flow Disposable Set
Description:	fluid warming system
Medical Device Identifier:	Model 24355 Lot Numbers: HX 7223 and HX 7270
Reason of Field Safety Corrective Action:	3M received two customer reports of leaks associated with 3M Ranger High Flow Disposable Set, Model 24355, Lots HX 7223 and HX 7270.
Remedy Action:	1. Determine of any stock of the 3M ranger High Flow Disposable Set model 24355 with the referenced lot numbers above remains in your inventory is to be discontinued immediately. 2. All affected lot numbers currently available your premises will be collected by our distributor and will be sent immediately to 3M. 3. 3M will be replacing the remaining affected quantities at your premises free of change. 4. Complete and return an undersigned copy of the enclosed return certification form by email to: Mr. Osama Romeh oromeh@mmm.com and Eng. Mohammed Alsamhan malsamhan@mmm.com 5. Contact Mr. Osama Romeh oromeh@mmm.com for product's replacement This recall should be carried out to the medical facility level.
Athorized Representative/Importer/Distributor:	3M company
Report Source:	NCMDR
Source Ref. Number:	9DD4D322D1337
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	3M.pdf

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