Mallinckrodt, Inc.

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1745-2022Class IIINOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inJune 23, 2022
D-1132-2015Class IIMD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound IodMay 15, 2015
D-1692-2012Class IIIThallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019NJuly 30, 2012
D-1431-2012Class IIHydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bMay 25, 2012
D-1430-2012Class IIIHydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bMay 25, 2012
Z-2081-2012Class IIThe Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in lenFebruary 1, 2010

Recent 510(k) Clearances

K-NumberDeviceDate
K003075KNIGHTSTAR 330 VENTILATORDecember 11, 2001
K003315SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULANovember 8, 2000