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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 039 10 18 000
Date submitted: 10/11/2018
Manufacturer:Atrium Medical Corporation
Device Type:ATRIUM OCEAN, OASIS, EXPRESS and EXPRESS MINI CHEST DRAINS
Description:Water Seal Chest Drain
Medical Device Identifier:All Lot Numbers With Expiration Date Prior To October 2019
Reason of Field Safety Corrective Action:This letter is intended to provide clarification about the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products. Atrium chest drainage products are packaged with a double sequential sterile wrap and placed into an outer dust cover. The dust cover is folded over and secured with the package label.

This packaging system is the same configuration used on Atrium chest drainage products for the past 30 years. This Field Notification is to provide clarification as to which part of the packaged drain is sterile.

The label on the outer package denotes the product as being sterile. The chest drain inside the packaging is sterile; the outer dust cover is not sterile. The two sterilization wraps are what provide the sterile barrier for the product.
Remedy Action:•Please ensure that all Atrium chest drain users are aware of the new warning label.

•Please make copies of new warning label (ref. Attachment 2 in the attached FSN) and post the warning label near all Atrium chest drain product inventory with expiration date prior to October 2019.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:2E5E0143B7187
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Atrium Medical Corporation.pdf