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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Swissmedic Recall
Reference Number: mdprc 018 09 21 000
Date submitted: 9/15/2021
Manufacturer:DJO, LLC.
Device Type:CHATTANOOGA ultrasound gel and lotions
Description:Coupling gel, non-sterile
Medical Device Identifier:DJO Part # 4238, 4248, 4266, 4262, 4260, 4210, 4208
Product Description: GEL CONDUCTOR 5 LITER W/DISP, GEL CONDUCTOR 24-8.5OZ BOTTLES, GEL CONDUCTIVE 5 LITER, Ultra-Myossage Lotion 1-gallon bottle, Ultra-Myossage Lotion 8.5oz, Myossage Lotion 1-gallon bottle, Myossage Lotion 8.5oz

Please see attached FSN for kit part numbers
Reason of Field Safety Corrective Action:Bacterial contamination in the affected lots of ultrasound gel with Burkholderia cepacian complex (Bcc)
Remedy Action:1.Immediately remove and destroy the gel products located in the DJO, LLC kits as listed in the FSN.

2.Immediately stop use of ALL ultrasound gels and Myossage lotions labeled manufactured by Eco-Med Pharmaceutical and/or for CHATTANOOGA (regardless of lot) and dispose per local/state or country specific regulation.
Athorized Representative/Importer/Distributor:Care Techniques Est.
Report Source:Swissmedic
Source Ref. Number:Vk_20210830_19
SFDA Comments:SFDA urges all hospitals that have devices subjected to this FSCA to contact the company.
Attachments: DJO. LLC.pdf