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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 103 01 18 000
3M Health Care Ltd
3M™ Bair Hugger™ Full Access Underbody Warming Blanket
Warming Units, Patient, Forced-Air
Medical Device Identifier:
1) 3MTM Bair Hugger™ Full Access Underbody Warming Blanket 63500
Lot Nos.: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366
2) 3MTM Bair Hugger™ Full Access Underbody Warming Blanket 63700
Lot Nos.: FR10361
Reason of Field Safety Corrective Action:
3M confirmed that that the affected blankets are more susceptible to unintended occlusion of airflow resulting in partial or limited inflation during use. If blankets are only partially inflated during use in surgery, there is potential for incomplete warming therapy to be given to a patient.
Please dispose of all affected product per your institutional protocol and document disposal in the recall acknowledgment form.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
3M Health Care.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.