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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 072 11 16 000
Date submitted: 11/14/2016
Manufacturer:Unimed Surgical Products, Inc
Device Type:Unicryl, Unicaprone, Unicryl Quick, Uniglactin, Unicryl M
Description:Absorbable Surgical Sutures
Medical Device Identifier:See Attachment for details
Reason of Field Safety Corrective Action:This letter to inform you that manufacturer have identified that the Suture Breaking Strength in few incidents are non compliant to European Pharmacopeia requirements.
Remedy Action:1. Immediately identify and quarantine all unused, affected products in your inventory.

2. Return all unused, affected products in your inventory to Unimed. Our Representatives will assist you in the return of affected product as necessary.
Athorized Representative/Importer/Distributor:Majal Care for Trading Est.
Report Source:NCMDR
Source Ref. Number:A395187D7C249, 05459FD29E259, D06C9E3B24239
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Unimed Field Saftey Notice0001.pdf