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.
June 11, 2014Medical DevicesFDA
Hospira Inc. recalls Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion S
Hazard: There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion
June 11, 2014Medical DevicesFDA
Hospira Inc. recalls Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intr
Hazard: There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion
June 11, 2014Medical DevicesFDA
Hospira Inc. recalls LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intraven
Hazard: There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion
June 11, 2014DrugsFDA
Hospira Inc. recalls Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, I
Hazard: Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
May 28, 2014Medical DevicesFDA
Hospira Inc. recalls LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Fle
Hazard: The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
May 28, 2014Medical DevicesFDA
Hospira Inc. recalls LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; Li
Hazard: The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
May 28, 2014Medical DevicesFDA
Hospira Inc. recalls LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For
Hazard: The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
May 28, 2014Medical DevicesFDA
Hospira Inc. recalls LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation
Hazard: The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
May 28, 2014Medical DevicesFDA
Hospira Inc. recalls LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list
Hazard: The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
May 7, 2014Medical DevicesFDA
Hospira Inc. recalls GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemS
Hazard: There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjunction with a GemStar Phase 3 pump (List 13000-XX, 13100-XX, or 13150-XX) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the Docking Station, and 2) when either a GemStar Phase 3 (List 13000-XX, 13100-XX, or 13150-XX)or GemStar Phase 4 pump (List 13086-XX, 13087-XX, or 13088-XX) is used in conjunction with both a Docking Station and an External Battery Pack accessory (List 13073-XX) there exists a possibility that the GemStar pump will display error code 11/003 and give an audible alarm indicating excessive input voltage from the external sources. If the GemStar pump detects what is perceived to be more than 3.6 Volts measured on the external voltage input, the pump will stop the infusion and alarm both with an audible sound as well as a visual alarm.
May 7, 2014Medical DevicesFDA
Hospira Inc. recalls Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cel
Hazard: Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.
May 7, 2014Medical DevicesFDA
Hospira Inc. recalls Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell compone
Hazard: Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.
May 7, 2014DrugsFDA
Hospira Inc. recalls Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira
Hazard: Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
April 30, 2014Medical DevicesFDA
Hospira Inc. recalls LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and I
Hazard: Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a HemoSet containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL.
April 30, 2014DrugsFDA
Hospira Inc. recalls Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, H
Hazard: Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide
April 23, 2014DrugsFDA
Hospira, Inc. recalls 1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.
Hazard: Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
April 16, 2014DrugsFDA
Hospira Inc. recalls Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc., La
Hazard: Labeling; Missing label; ampoules are missing the immediate container label
March 26, 2014DrugsFDA
Hospira Inc. recalls Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials
Hazard: Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
March 12, 2014Medical DevicesFDA
Hospira Inc. recalls *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch
Hazard: Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly.
March 12, 2014DrugsFDA
Hospira Inc. recalls Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest,
Hazard: Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
March 12, 2014DrugsFDA
Hospira Inc. recalls 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-
Hazard: Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.
February 5, 2014DrugsFDA
Hospira Inc. recalls Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. H
Hazard: Lack of Assurance of Sterility; potential leakage from administrative port.
February 5, 2014DrugsFDA
Hospira Inc. recalls Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL
Hazard: Lack of Assurance of Sterility; potential leakage from administrative port.
January 29, 2014DrugsFDA
Hospira Inc. recalls Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20
Hazard: Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.
January 22, 2014DrugsFDA
Hospira Inc. recalls Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, N
Hazard: Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
January 8, 2014DrugsFDA
Hospira Inc. recalls 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake For
Hazard: Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
December 25, 2013DrugsFDA
Hospira Inc. recalls 0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-
Hazard: Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
December 25, 2013DrugsFDA
Hospira Inc. recalls 0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-
Hazard: Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
December 18, 2013Medical DevicesFDA
Hospira Inc. recalls Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospir
Hazard: Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating.
December 11, 2013DrugsFDA
Hospira, Inc. recalls Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02),
Hazard: Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.