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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 034 12 15 000
Date submitted: 12/10/2015
Manufacturer:Cook Medical
Device Type:VentriClear® II Ventricular Drainage Catheter Set
Description:Catheter
Medical Device Identifier:50318 (5 pack)

GPN Number: G44130

LotNumbers: F4365351X, F4692818X,NS5274254X, NS5667436X,NS5727900X,NS6079165X, NS6079166X
Reason of Field Safety Corrective Action:Cook Medical has discovered internally that these specific lot numbers have been sterilized a total of two (2) times before shipment. The concentrations/amounts of minocycline and rifampin present on each catheter are known to decrease after each sterilization cycle.
Remedy Action:1. Please review the affected product and lot numbers shipped to your account, and quarantine any affected product that remains unused.

2. Please complete the attached Recall Response Form.

3. Immediately collect and return all unused affected products to Medtronic as soon as possible for credit (See attached Recall Response Form for instructions).

4. Contact your local Medtronic Representative at Gulf Medical for replacement product.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:2DDE23DB8F298
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Cook medical.pdf