Manufacturer

Hospira, Inc.

257 recalls in our database name Hospira, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 257
Critical: 18
Severe: 104
Most recent: 2017-05-31

Of the 257 recalls from Hospira, Inc. we have scored against our rubric, 18 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 104 (40%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 257

SevereFDA (Devices)·Z-2139-2016·2016-07-20
Hospira Recalls LifeCare PCA Plus II Infusion Pumps Due to Occlusion Detection Failure
Hospira is recalling 53,151 LifeCare PCA Plus II infusion pumps because wear on a component may prevent the detection of distal occlusions, resulting in serious injury.
Product
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncol
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2141-2016·2016-07-20
Hospira Recalls LifeCare PCA Infusion Systems Due to Occlusion Detection Failure
Hospira is recalling 38,878 LifeCare PCA infusion systems because wear on a component may prevent the pump from detecting distal occlusions, a defect that has resulted in one serious injury.
Product
LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1359-2016·2016-07-20
Hospira Recalls Diazepam Injection Due to Crystallized Active Ingredient
Hospira Inc. is recalling 373,850 tubes of Diazepam Injection USP 10mg/2mL because the product contains particulate identified as crystallized active ingredient.
Product
DIAZEPAM — DIAZEPAM (DIAZEPAM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2142-2016·2016-07-20
Hospira LifeCare Pump Model 4200 PCA Infuser Recalled for Occlusion Detection Failure
Hospira is recalling 6,268 LifeCare Pump Model 4200 PCA Infusers because they may fail to detect distal occlusions, a defect that caused one serious injury.
Product
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1137-2016·2016-07-13
Hospira Recalls Magnesium Sulfate Injection Due to Particulate Matter
Hospira Inc. is recalling specific lots of Magnesium Sulfate Injection due to confirmed particulate matter. The recall covers 88,500 vials distributed in the US and several Middle Eastern countries.
Product
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 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2060-2016·2016-07-06
Hospira Recalls PlumSet IV Administration Sets Due to Fluid Leakage
Hospira is recalling PlumSet IV administration sets because intravenous fluid may leak at the secondary port. The recall covers 3,920,932 units distributed in the US and Canada.
Product
*** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2058-2016·2016-07-06
Hospira Recalls PlumSet IV Administration Sets Due to Fluid Leakage
Hospira is recalling specific PlumSet IV administration sets because intravenous fluid may leak at the CLAVE secondary port.
Product
*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2061-2016·2016-07-06
Hospira Recalls IV Administration Sets Due to Fluid Leakage Risk
Hospira is recalling specific lots of Lifeshield IV administration sets because intravenous fluid may leak at the secondary port.
Product
*** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2055-2016·2016-07-06
Hospira Symbiq Infusion Pumps Recalled for Frequent False Occlusion Alarms
Hospira is recalling Symbiq One Channel Infusers due to frequent false proximal occlusion alarms that may delay or interrupt patient therapy.
Product
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2056-2016·2016-07-06
Hospira Symbiq Infusion Pumps Recalled for False Occlusion Alarms
Hospira is recalling Symbiq Two Channel Infusers due to frequent false occlusion alarms that may delay or interrupt patient therapy.
Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2062-2016·2016-07-06
Hospira Recalls LifeShield IV Sets Due to Potential Fluid Leakage
Hospira is recalling approximately 3.9 million LifeShield IV administration sets because fluid may leak at the secondary port.
Product
*** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: List No. 19685-28; L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2059-2016·2016-07-06
Hospira Recalls LifeShield IV Administration Sets Due to Fluid Leakage
Hospira is recalling specific LifeShield IV administration sets because intravenous fluid may leak at the CLAVE secondary port.
Product
*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML; *** 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD PLU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1033-2016·2016-06-22
Hospira Recalls Vancomycin Hydrochloride Injection Due to Cardboard Particulate Matter
Hospira Inc. is recalling specific lots of Vancomycin Hydrochloride for Injection due to the presence of cardboard particulate matter.
Product
Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1832-2016·2016-06-15
Hospira Recalls 1,490 Plum 360 Infusion Pumps Due to Calibration Error
Hospira is recalling 1,490 Plum 360 infusion pumps because a calibration error may cause false proximal occlusion alarms.
Product
The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery from one or more r
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1833-2016·2016-06-15
Hospira Recalls 2,567 Plum A+ Infusion Pumps Due to Calibration Error
Hospira is recalling 2,567 Plum A+ infusion pumps because a calibration error caused false occlusion alarms. The devices were distributed in the U.S. and 13 foreign countries.
Product
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0865-2016·2016-06-01
Hospira Recalls Sodium Bicarbonate Injection Due to Insect Particulate Matter
Hospira Inc. is recalling 72,000 units of 8.4% Sodium Bicarbonate Injection because an insect was found in one vial.
Product
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0854-2016·2016-05-25
Hospira Recalls Magnesium Sulfate Injection Due to pH Failures
Hospira Inc. is recalling 715,200 vials of Magnesium Sulfate Injection, USP 50% due to confirmed high out-of-specification pH results.
Product
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 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0836-2016·2016-05-11
Hospira Recalls Quelicin Injection Due to Faded or Missing Label Dates
Hospira Inc. is recalling 103,600 vials of Quelicin (Succinylcholine Chloride) Injection because the lot number or expiration date may be faded or missing from the primary label.
Product
QUELICIN — QUELICIN (SUCCINYLCHOLINE CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0829-2016·2016-04-27
Hospira Recalls Dextrose Injection Bags Due to Chemical Contamination Risk
Hospira Inc. is recalling 552 bags of Dextrose Injection, USP, 20% due to potential contamination with an aromatic hydrocarbon resin.
Product
Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0828-2016·2016-04-27
Hospira Recalls Dextrose Injection Bags Due to Chemical Contamination
Hospira Inc. is recalling 4,368 bags of Dextrose Injection, USP, 50% due to potential contamination with an aromatic hydrocarbon resin.
Product
Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0832-2016·2016-04-27
Hospira Recalls Potassium Chloride Injection Bags Due to Chemical Contamination
Hospira Inc. is recalling 81,888 bags of Potassium Chloride Injection due to potential contamination with an aromatic hydrocarbon resin.
Product
Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0831-2016·2016-04-27
Hospira Recalls Mannitol I.V. Bags Due to Chemical Contamination Risk
Hospira Inc. is recalling 22,292 bags of Mannitol I.V. 20% due to potential contamination with an aromatic hydrocarbon resin.
Product
Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0830-2016·2016-04-27
Hospira Recalls Aminosyn-PF Amino Acid Bags Due to Chemical Contamination
Hospira Inc. is recalling 1,776 bags of Aminosyn-PF (amino acids) 7% due to potential contamination with an aromatic hydrocarbon resin.
Product
Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0827-2016·2016-04-27
Hospira Recalls Dextrose Injection Bags Due to Chemical Contamination Risk
Hospira is recalling 11,256 bags of Dextrose Injection, USP, 70% due to potential contamination with an aromatic hydrocarbon resin.
Product
Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0863-2016·2016-03-02
Hospira Symbiq Infusion Pumps Recalled for Missing Rubber Stop Pad
Hospira is recalling 6,634 Symbiq infusion pumps because the pole clamp assemblies may be missing a rubber stop pad. The devices were distributed to healthcare facilities in the U.S. and Canada.
Product
The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes, Mobi
Category
Medical Device
Distribution
Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Hospira

American pharmaceutical company

Country: United States
Founded: 2004
Parent company: Pfizer

Official website

Source: Wikidata (Q1470525), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.