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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 029 06 14 000
Date submitted: 6/10/2014
Manufacturer:The Anspach Effort, Inc.
Device Type:STERRAD 100S Hydrogen Peroxide Gas Plasma Technology (STERRAD® 100S) for sterilization.
Description:CLEANING & STERILIZATION
Medical Device Identifier:DFU : 18-0047 Title : DFU, IMRI MOTOR Revisions : A & B

DFU : 18-0074 Title : CLEANING & STERILIZATION DFU Revisions : A

DFU : 18-0105 Title : CLEANING & STERILIZATION DFU Revisions : A

Operating Manual: 0X6.001.506 Title : Anspach Pneumatic Systems User's Manual Revisions : AA

Operating Manual: 0X6.001.507 Title : High Speed Electric User's Manual Revisions : AA, AB

Operating Manual: 19-0010 Title : Anspach Pneumatic Systems User's Manual Revisions : A

Operating Manual: 19-0013 Title : High Speed Electric User's Manual Revisions : A, B & C
Reason of Field Safety Corrective Action:The company identified through internal testing of STERRAD® 100S sterilization process that several Anspach attachments did not achieve the expected sterility assurance level (SAL) of 10⁻⁶ .
Remedy Action:Please note that it is no longer recommended to use STERRAD 100S to sterilize Anspach products. The manufacturer is removing the recommendation to sterilize Anspach product with STERRAD 100S.
Athorized Representative/Importer/Distributor:Al-Nozha Medical Est, (012) 6534664
Report Source:NCMDR
Source Ref. Number:830B45B0651E8
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: The Anspach Effort.pdf