Bracco Diagnostic Inc

FDA Regulatory Profile

Summary

Total Recalls
6 (2 Class I)
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1147-2015Class IIIE-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, ManufacMay 27, 2015
D-0014-2015Class IIIE-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, ManuSeptember 18, 2014
D-1536-2014Class IIIE-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM CanaJuly 2, 2014
D-158-2013Class IIsovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, ManufaNovember 21, 2012
D-157-2013Class IIsovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 027November 21, 2012
D-095-2013Class IIICholetec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, NonradioactiveAugust 14, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K132192BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATORFebruary 14, 2014
K123047BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SETAugust 6, 2013
K111648BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATORNovember 3, 2011