Hospira Recalls
257 recalls on record · June 20, 2012 to May 31, 2017 · Drugs, Medical Devices
Recalls by year
12
13
14
15
16
17
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 31, 2017DrugsFDA
Hospira Inc. recalls Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospir
Hazard: Presence of Particulate Matter: human hair found within an internal sample syringe.
January 18, 2017Medical DevicesFDA
Hospira Inc. recalls Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of dru
Hazard: Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This occlusion has the potential to prevent the set from being primed for use and cause a delay in therapy.
December 14, 2016DrugsFDA
Hospira Inc. recalls 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia
Hazard: Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
November 30, 2016DrugsFDA
Hospira Inc. recalls Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 6
Hazard: Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
November 16, 2016Medical DevicesFDA
Hospira Inc. recalls Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note
Hazard: May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of therapy.
November 16, 2016Medical DevicesFDA
Hospira Inc. recalls Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note
Hazard: May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of therapy.
November 9, 2016Medical DevicesFDA
Hospira Inc. recalls Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
Hazard: Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.
November 9, 2016Medical DevicesFDA
Hospira Inc. recalls Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
Hazard: Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.
November 2, 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: Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury.
November 2, 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 pur
Hazard: Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury.
September 28, 2016Medical DevicesFDA
Hospira Inc. recalls LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic
Hazard: Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops.
September 28, 2016Medical DevicesFDA
Hospira Inc. recalls LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administ
Hazard: Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops.
September 21, 2016DrugsFDA
Hospira Inc. recalls DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx
Hazard: Discoloration: Firm received complaints of product discoloration and particulates.
September 14, 2016Medical DevicesFDA
Hospira Inc. recalls Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpos
Hazard: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
September 14, 2016Medical DevicesFDA
Hospira Inc. recalls Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that prov
Hazard: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
September 14, 2016Medical DevicesFDA
Hospira Inc. recalls Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices th
Hazard: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
September 14, 2016Medical DevicesFDA
Hospira Inc. recalls Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose
Hazard: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
September 14, 2016Medical DevicesFDA
Hospira Inc. recalls Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose
Hazard: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
September 14, 2016Medical DevicesFDA
Hospira Inc. recalls Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that prov
Hazard: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
September 14, 2016Medical DevicesFDA
Hospira Inc. recalls Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provi
Hazard: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
September 14, 2016Medical DevicesFDA
Hospira Inc. recalls Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provi
Hazard: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
September 14, 2016Medical DevicesFDA
Hospira Inc. recalls Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of device
Hazard: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
August 24, 2016Medical DevicesFDA
Hospira Inc. recalls Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01;
Hazard: Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 1.5 L liner, 2L liner or 3L liner with a 1L canister. It is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent.
August 24, 2016Medical DevicesFDA
Hospira Inc. recalls Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000, with Valve 1) List Numbers 43
Hazard: Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 1.5 L liner, 2L liner or 3L liner with a 1L canister. It is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent.
July 20, 2016Medical DevicesFDA
Hospira Inc. recalls The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. Th
Hazard: 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 component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.
July 20, 2016Medical DevicesFDA
Hospira Inc. recalls LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administe
Hazard: 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 component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.
July 20, 2016Medical DevicesFDA
Hospira Inc. recalls The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/de
Hazard: 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 component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.
July 20, 2016Medical DevicesFDA
Hospira Inc. recalls The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through th
Hazard: 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 component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.
July 20, 2016DrugsFDA
Hospira Inc. recalls Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
Hazard: Crystallization: Product contains particulate identified to be crystallized active ingredient.
July 13, 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: Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.