Hospira, Inc. Recalls — U.S. Recall Records

Recall history in this database

Classification mix: Class II: 110, Class I: 31, Class III: 10.

Medical DeviceJul 20, 2016

Hospira The PCA 3 system cam be used in a wide range of clinical settings, including but not recall — FDA Z-2140-2016

Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the…

Class IIFDA: TerminatedHospira Inc.

Medical DeviceJul 20, 2016

Hospira The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation recall — FDA Z-2142-2016

Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the…

Class IIFDA: TerminatedHospira Inc.

Medical DeviceJul 20, 2016

Hospira LifeCare PCA infusion system with Hospira MedNet software allows clinicians to recall — FDA Z-2141-2016

Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the…

Class IIFDA: TerminatedHospira Inc.

DrugJul 13, 2016

Hospira Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL) recall — FDA D-1137-2016

Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.

Class IFDA: OngoingHospira Inc.

Medical DeviceJul 6, 2016

Hospira Symbiq One Channel Infuser recall — FDA Z-2055-2016

Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no…

Class IIFDA: TerminatedHospira Inc.

Medical DeviceJul 6, 2016

Hospira *** 1) Product labeled in part: 19734-28 recall — FDA Z-2061-2016

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

Class IIFDA: TerminatedHospira Inc.

Medical DeviceJul 6, 2016

Hospira *** 1) Product labeled in part: 19683-28 recall — FDA Z-2062-2016

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

Class IIFDA: TerminatedHospira Inc.

Medical DeviceJul 6, 2016

Hospira *** 1) Product labeled in part: List No. 14212-28 recall — FDA Z-2058-2016

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

Class IIFDA: TerminatedHospira Inc.

Medical DeviceJul 6, 2016

Hospira *** 1) Product labeled in part: 14951-48 recall — FDA Z-2059-2016

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

Class IIFDA: TerminatedHospira Inc.

Medical DeviceJul 6, 2016

Hospira *** 1) Product labeled in part: List No. 14220-28 recall — FDA Z-2060-2016

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

Class IIFDA: TerminatedHospira Inc.

Medical DeviceJul 6, 2016

Hospira Symbiq Two Channel Infuser recall — FDA Z-2056-2016

Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no…

Class IIFDA: TerminatedHospira Inc.

Medical DeviceJun 15, 2016

Hospira The Plum A+ is a dual-line volumetric infusion system designed to meet the growing recall — FDA Z-1833-2016

Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification…

Class IIFDA: TerminatedHospira Inc.

Medical DeviceJun 15, 2016

Hospira The Plum 360 is a large volume infuser capable of delivering fluids for a variety of recall — FDA Z-1832-2016

Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification…

Class IIFDA: TerminatedHospira Inc.

DrugMay 25, 2016

Hospira Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL) recall — FDA D-0854-2016

Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.

Class IIIFDA: OngoingHospira Inc.

DrugMay 11, 2016

Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose recall — FDA D-0836-2016

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.

Class IIIFDA: OngoingHospira Inc.

DrugApr 27, 2016

Hospira Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags recall — FDA D-0829-2016

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Class IIFDA: TerminatedHospira Inc.

DrugApr 27, 2016

Hospira Mannitol I.V., 20%, USP (20 g/ 100 mL) recall — FDA D-0831-2016

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Class IIFDA: TerminatedHospira Inc.

DrugApr 27, 2016

Hospira Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag recall — FDA D-0828-2016

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Class IIFDA: TerminatedHospira Inc.

DrugApr 27, 2016

Hospira Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag recall — FDA D-0827-2016

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Class IIFDA: TerminatedHospira Inc.

DrugMar 2, 2016

Hospira Normosol-M and 5% Dextrose recall — FDA D-0727-2016

Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".

Class IIIFDA: OngoingHospira Inc.

Medical DeviceMar 2, 2016

Hospira The Symbiq infusion pump is a device used in a health care facility to pump fluids recall — FDA Z-0863-2016

Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad.

Class IIFDA: TerminatedHospira Inc.

DrugFeb 24, 2016

Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL recall — FDA D-0668-2016

Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.

Class IFDA: TerminatedHospira Inc.

DrugOct 28, 2015

Hospira Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass recall — FDA D-0054-2016

Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.

Class IIIFDA: OngoingHospira Inc.

DrugSep 30, 2015

LIDOCAINE HYDROCHLORIDE 1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose recall — FDA D-1815-2015

Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.

Class IIFDA: OngoingHospira, Inc.

Understanding this recall history

This page summarizes recall records in which the official source identifies Hospira, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.