Hospira Recalls
257 recalls on record · June 20, 2012 to May 31, 2017 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 6, 2016Medical DevicesFDA
Hospira Inc. recalls *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CO
Hazard: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
July 6, 2016Medical DevicesFDA
Hospira Inc. recalls *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLA
Hazard: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
July 6, 2016Medical DevicesFDA
Hospira Inc. recalls *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, N
Hazard: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
July 6, 2016Medical DevicesFDA
Hospira Inc. recalls *** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AN
Hazard: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
July 6, 2016Medical DevicesFDA
Hospira Inc. recalls *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non
Hazard: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
July 6, 2016Medical DevicesFDA
Hospira Inc. recalls Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpo
Hazard: 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 occlusion present. False POAs could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace the pump.
July 6, 2016Medical DevicesFDA
Hospira Inc. recalls Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpo
Hazard: 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 occlusion present. False POAs could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace the pump.
June 22, 2016DrugsFDA
Hospira Inc. recalls Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01
Hazard: Presence of Particulate Matter: Cardboard
June 15, 2016Medical DevicesFDA
Hospira Inc. recalls The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as
Hazard: 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 metal cassette, resulting in an offset in proximal pressure.
June 15, 2016Medical DevicesFDA
Hospira Inc. recalls The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enter
Hazard: 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 metal cassette, resulting in an offset in proximal pressure.
June 1, 2016DrugsFDA
Hospira Inc. recalls 8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest,
Hazard: Presence of Particulate Matter: particulate matter identified as an insect in one vial.
May 25, 2016DrugsFDA
Hospira Inc. recalls Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vial
Hazard: Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
May 11, 2016DrugsFDA
Hospira Inc. recalls Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit via
Hazard: 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.
April 27, 2016DrugsFDA
Hospira Inc. recalls Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045,
Hazard: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
April 27, 2016DrugsFDA
Hospira Inc. recalls Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0
Hazard: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
April 27, 2016DrugsFDA
Hospira Inc. recalls Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-0
Hazard: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
April 27, 2016DrugsFDA
Hospira Inc. recalls Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 04
Hazard: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
April 27, 2016DrugsFDA
Hospira Inc. recalls Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 040
Hazard: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
April 27, 2016DrugsFDA
Hospira Inc. recalls Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 04
Hazard: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
March 2, 2016Medical DevicesFDA
Hospira Inc. recalls The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner
Hazard: Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad.
March 2, 2016DrugsFDA
Hospira Inc. recalls Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container
Hazard: 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".
February 24, 2016DrugsFDA
Hospira Inc. recalls Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hosp
Hazard: Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
October 28, 2015DrugsFDA
Hospira Inc. recalls Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock
Hazard: Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
September 30, 2015DrugsFDA
Hospira, Inc. recalls 1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Fores
Hazard: Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
September 23, 2015DrugsFDA
Hospira Inc. recalls Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx
Hazard: Defective Container: There were customer complaints of cracked and leaking glass vials.
July 22, 2015DrugsFDA
Hospira Inc. recalls KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Fores
Hazard: Crystallization; identified as calcium salt of Ketorolac
July 22, 2015DrugsFDA
Hospira Inc. recalls KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Fore
Hazard: Crystallization; identified as calcium salt of Ketorolac
July 22, 2015DrugsFDA
Hospira Inc. recalls 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, ND
Hazard: Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
July 15, 2015DrugsFDA
Hospira Inc. recalls Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospi
Hazard: Failed pH Specifications: 12 month stability testing
July 15, 2015DrugsFDA
Hospira Inc. recalls Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC.,
Hazard: Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.