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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 095 10 11 000
Date submitted: 10/31/2011
Manufacturer:Thomas Medical Products-Through Biotronik
Device Type:Various SafeSheath and Situs Products
Description:Cannulae, Coronary Sinus, Catheter Introducers-Hemostasis Valve
Medical Device Identifier:Catalog Nos: FCL-069-02, FCL-069-03 (Attached)
Reason of Field Safety Corrective Action:The radiopaque segment of the above catheters may detach during in vivo use, potentially resulting in device fragments remaining in the patient's vasculature.
Remedy Action:Immediately segregate all affected product in a manner that ensures it will not be used. 2. Return any product with reference to the return authorization (RA) number on the product reconciliation form, or contact your customer service representative at the phone number listed below to facilitate return of the affected product. 3. If any affected product has been forwarded to another facility, contact that facility to arrange return. 4. By returning product, you attest that you have returned all unused product in your inventory.
Athorized Representative/Importer/Distributor:GE Healthcare. Riyadh (01) 4600530
Report Source:NCMDR
Source Ref. Number:CDAB56CDFE399
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Thomas Medical Products-Through Biotronik.pdf