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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 004 11 18 000
Date submitted: 11/5/2018
Manufacturer:Atrium Medical Corporation
Device Type:ATRIUM PVC Thoracic Catheter
Description:Catheters
Medical Device Identifier:Product Code: 8128
Affected Lot Number: ME221275
Reason of Field Safety Corrective Action:This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom.
Remedy Action:1.Examine your inventory to determine if you have the affected product listed in this Notification. If so, remove affected products, quarantine them, and place in a secure location.

2.If you are a DISTRIBUTOR who has shipped any affected products to your customers, immediately forward copies of this notification including the form to their attention for appropriate action.

3.If you have affected product, please contact fathima.nuskiya@getinge.com to request return authorization and shipping instructions to return any affected product for credit or exchange. Pack the product to be returned with the appropriate return documents, using the shipping instructions provided.

4.Please complete and sign the response form to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to mubashir.javed@getinge.com
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:01F48DAF4D27E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Atrium Medical Corporation.pdf