Hospira, Inc.

FDA Regulatory Profile

Summary

Total Recalls
257 (62 Class I)
510(k) Clearances
45
Inspections
50
Compliance Actions
4

Recent Recalls

NumberClassProductDate
D-0862-2017Class IInfant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carApril 21, 2017
D-0153-2017Class IIFentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, InNovember 1, 2016
D-1500-2016Class IIDOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (August 15, 2016
D-0169-2017Class III5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, FoJune 29, 2016
D-1359-2016Class IIDiazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0June 23, 2016
D-1033-2016Class IIVancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NMay 6, 2016
Z-1832-2016Class IIThe Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such March 25, 2016
Z-1833-2016Class IIThe Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospitMarch 25, 2016
D-0854-2016Class IIIMagnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial,March 23, 2016
D-1137-2016Class IMagnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial,March 23, 2016
D-0865-2016Class I8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, HospirMarch 18, 2016
D-0836-2016Class IIIQuelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, pacMarch 15, 2016
D-0831-2016Class IIMannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake ForestMarch 8, 2016
D-0829-2016Class IIDextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake ForesMarch 8, 2016
D-0828-2016Class IIDextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake ForestMarch 8, 2016
D-0830-2016Class IIAminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 600March 8, 2016
D-0832-2016Class IIPotassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., LakeMarch 8, 2016
D-0827-2016Class IIDextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake ForesMarch 8, 2016
D-0727-2016Class IIINormosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL SiFebruary 2, 2016
D-0668-2016Class IMagnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-DoseJanuary 5, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleMarch 28, 2017
K161036Hospira Extension Set, Hospira Primary SetJanuary 6, 2017
K160492Hospira Sapphire SetsDecember 6, 2016
K160870Hospira Administration SetsJune 1, 2016
K143612LifeCare PCA Infusion SystemApril 8, 2016
K143087Hospira Blood SetMarch 4, 2015
K143015Hospira Primary SetsFebruary 25, 2015
K141789PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSJanuary 16, 2015
K142622IV AdministrationJanuary 15, 2015
K142974Extension SetsJanuary 9, 2015
K142433Hospira Extension SetDecember 8, 2014
K142367Hospira Primary SetsNovember 25, 2014
K141102HOSPIRA MEDNET MEDICATION MANAGEMENT SUITEJuly 8, 2014
K133602ADD-VANTAGE ADDAPTORJanuary 24, 2014
K132276STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONNovember 12, 2013
K121032PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHPJune 21, 2012
K110901SYMBIQ INFUSION AND ADMINSTRATION SETMarch 5, 2012
K113683LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEALJanuary 12, 2012
K103224HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBINGJanuary 7, 2011
K103344INFUSION SETSDecember 10, 2010