Your changes have been successfully saved
Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 137 04 16 000
3M Health Care Ltd
3M Ranger High Flow Disposable Set
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.
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 email@example.com and Eng. Mohammed Alsamhan firstname.lastname@example.org
5. Contact Mr. Osama Romeh email@example.com for product's replacement This recall should be carried out to the medical facility level.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.