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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 019 04 16 000
Date submitted: 4/5/2016
Manufacturer:Stryker Neurovascular
Device Type:GDC 360 Detachable Coils
Description:Complex Coils
Medical Device Identifier:Catalog #: M00334811300 & M0033471020SR0 Lot Code: 17074659, 17723781, 17735100
Reason of Field Safety Corrective Action:Stryker Neurovascular has become aware that the incorrect DFU was included with the above listed product.
Remedy Action:1. Immediately check your internal inventory.

2. The affected items may continue to be used.

3. Please follow the instructions listed in the Directions For Use (DFU) accompanying this notice.

4. Circulate this Field Safety Notice internally to all interested/affected parties.

5. Maintain awareness of this notice internally until all required actions have been completed within your facility

6. Inform Stryker if any of the subject devices have been distributed to other organizations.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY
Report Source:NCMDR
Source Ref. Number:42038C07BD195
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Stryker Neurovascular.pdf