SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

Reference Number:	mdprc 003 07 11 000
Date submitted:	7/3/2011

Manufacturer:	Ohio Medical Corporation
Device Type:	AC Powered Portable Aspirator
Description:	Aspirators, Emergency
Medical Device Identifier:	Care-E-Vac 3 Battery AC Portable Aspirator, Model: 758000
Reason of Field Safety Corrective Action:	Ohio Medical Corporation had one complaint regarding a screw used to attach one of the feet of the unit. If the screw is over tightened, it may potentially damage the battery inside the device.
Remedy Action:	Take Care-E-Vac 3 Battery AC Portable Aspirator out of service at the earliest possible convenience. Replace the current foot screw on the unit with the new blunt edged replacement screw that was sent to you with the two previous notifications.
Athorized Representative/Importer/Distributor:	ABDULREHMAN AL GOSAIBI GTB, Riyadh (01) 4771374
Report Source:	NCMDR
Source Ref. Number:	11C5E58620261
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments:	Ohio_Medical_Corporation__-_June_2011[1].pdf

View History