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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 027 07 12 000
Date submitted: 7/10/2012
Manufacturer:AngioDynamics
Device Type:Catheters, Soft-Vu Angiographic Catheter
Description:Catheters, Cardiac, Angiography
Medical Device Identifier:Product Description ( CatalogNumber, Lot Number): Soft-Vu® Angiographic Catheter JB(1) Non-Braided 5F x 100cm x 0.035” (10734201, 564325)
Reason of Field Safety Corrective Action:A potential for the product to be mislabeled. The outer box is labeled as Soft-Vu® Angiographic Catheter, JB (1) Non-Braided 5F x 100cm x .035”; however, the potential exists that the pouch within may be labeled as a Soft-Vu® Angiographic Catheter Kerns with (1) Side Hole Braided 4F x 65cm x .035”
Remedy Action:Immediately remove the recalled product from your inventory (whether in Labs, Central Supply, Shipping and Receiving or ANY other location). Segregate this product in a secure location for return to AngioDynamics, Inc.
Athorized Representative/Importer/Distributor:Al Hammad Medical Services, Riyadh, (01) 4659811
Report Source:NCAR
Source Ref. Number:UK-2012-07-05-127
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: AngioDynamics.pdf