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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 103 01 18 000
Date submitted: 1/31/2018
Manufacturer:3M Health Care Ltd
Device Type:3M™ Bair Hugger™ Full Access Underbody Warming Blanket
Description: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.
Remedy Action:Please dispose of all affected product per your institutional protocol and document disposal in the recall acknowledgment form.
Athorized Representative/Importer/Distributor:3M company
Report Source:NCMDR
Source Ref. Number:78824E1BD0233
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: 3M Health Care.pdf