Company ยท US
Hospira Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2017. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (0 in 12 months)
290recalls (0 in 12 months)
273recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FRN | Pump, Infusion | 141 |
| FPA | Set, Administration, Intravascular | 123 |
| BRZ | Set, Blood Transfusion | 13 |
| MEA | Pump, Infusion, Pca | 13 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 6 |
| DQE | Catheter, Oximeter, Fiber-Optic | 5 |
| DQO | Catheter, Intravascular, Diagnostic | 5 |
| KDC | Instrument, Surgical, Disposable | 4 |
| GBX | Catheter, Irrigation | 3 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 3 |
| DRS | Transducer, Blood-Pressure, Extravascular | 2 |
| FPK | Tubing, Fluid Delivery | 2 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 2 |
| KPE | Container, I.V. | 2 |
| LJH | System, Irrigation, Urological | 2 |
| NGT | Saline, Vascular Access Flush | 2 |
| DNN | Calibrators, Ethyl Alcohol | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 |
| IQG | Adaptor, Holder, Syringe | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 28, 2017 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module Hospira, Inc. | FRN |
| Jan 6, 2017 | K161036 | Hospira Extension Set, Hospira Primary Set Hospira, Inc. | FPA |
| Dec 6, 2016 | K160492 | Hospira Sapphire Sets Hospira, Inc. | MRZ |
| Jun 1, 2016 | K160870 | Hospira Administration Sets Hospira, Inc. | FPA |
| Apr 8, 2016 | K143612 | LifeCare PCA Infusion System Hospira, Inc. | MEA |
| Mar 4, 2015 | K143087 | Hospira Blood Set Hospira, Inc. | FPA |
| Feb 25, 2015 | K143015 | Hospira Primary Sets Hospira, Inc. | FPA |
| Jan 16, 2015 | K141789 | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE Hospira, Inc. | FRN |
| Jan 15, 2015 | K142622 | IV Administration Hospira, Inc. | FPA |
| Jan 9, 2015 | K142974 | Extension Sets Hospira, Inc. | FPA |
| Dec 8, 2014 | K142433 | Hospira Extension Set Hospira, Inc. | FPA |
| Nov 25, 2014 | K142367 | Hospira Primary Sets Hospira, Inc. | FPA |
| Jul 8, 2014 | K141102 | HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE Hospira, Inc. | FRN |
| Jan 24, 2014 | K133602 | ADD-VANTAGE ADDAPTOR Hospira, Inc. | LHI |
| Nov 12, 2013 | K132276 | STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML Hospira, Inc. | KPE |
| Jun 21, 2012 | K121032 | PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP Hospira, Inc. | FPA |
| Mar 5, 2012 | K110901 | SYMBIQ INFUSION AND ADMINSTRATION SET Hospira, Inc. | FRN |
| Jan 12, 2012 | K113683 | LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL Hospira, Inc. | FPA |
| Jan 7, 2011 | K103224 | HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING Hospira, Inc. | FPA |
| Dec 10, 2010 | K103344 | INFUSION SETS Hospira, Inc. | FPA |
| Aug 11, 2010 | K101677 | HOSPIRA INFUSION BLOOD SETS Hospira, Inc. | FPA |
| Apr 23, 2010 | K090882 | FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE Hospira, Inc. | NGT |
| Sep 18, 2009 | K091268 | HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS Hospira, Inc. | DQE |
| Mar 13, 2009 | K090610 | HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM Hospira, Inc. | DRG |
| Dec 17, 2008 | K081412 | PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc. | FRN |
| Oct 22, 2008 | K083019 | GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE Hospira, Inc. | FRN |
| Sep 11, 2008 | K080579 | EFFECTIV (TM) CAP Hospira, Inc. | QBP |
| Apr 24, 2007 | K070398 | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 Hospira, Inc. | FRN |
| Dec 11, 2006 | K063239 | LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 Hospira, Inc. | FPK |
| Dec 11, 2006 | K063180 | ISECURE SYRINGE CARTRIDGE HOLDER Hospira, Inc. | IQG |
| Nov 3, 2006 | K062999 | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN Hospira, Inc. | DQE |
| Oct 5, 2006 | K061585 | OPTICATH CENTRAL VENOUS OXIMETRY CATHETER Hospira, Inc. | DQE |
| Sep 19, 2006 | K061573 | TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT Hospira, Inc. | DRS |
| Sep 11, 2006 | K061432 | HOSPIRA ENTERAL FEEDING SET, MODEL 20640 Hospira, Inc. | KNT |
| Aug 4, 2006 | K061450 | HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS Hospira, Inc. | DQE |
| Jun 26, 2006 | K061159 | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN Hospira, Inc. | DQE |
| Apr 21, 2006 | K060806 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 Hospira, Inc. | FRN |
| Feb 17, 2006 | K052828 | DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) Hospira, Inc. | DRS |
| Nov 2, 2005 | K052722 | LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS Hospira, Inc. | FPA |
| Aug 24, 2005 | K052052 | HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 Hospira, Inc. | FRN |
| Dec 6, 2004 | K043256 | HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 Hospira, Inc. | MEA |
| Nov 17, 2004 | K042980 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE Hospira, Inc. | FRN |
| Oct 18, 2004 | K042800 | LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc. | MEA |
| Oct 6, 2004 | K042609 | HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE Hospira, Inc. | FRN |
| Aug 24, 2004 | K042081 | PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc. | FRN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2017 | Hospira Inc. Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free
Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device. Terminated |
FPK | K941214 |
| Sep 6, 2016 | Hospira Inc. Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clini Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum o Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clini Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinic Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinic Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectr Terminated |
FRN | K081412 |
| Mar 25, 2016 | Hospira Inc. 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, seco Terminated |
FRN | K141789 |
| Mar 25, 2016 | Hospira Inc. 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 Terminated |
FRN | K141789 |
| Dec 22, 2015 | Hospira Inc. 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 o Terminated |
FRN | K110901 |
| Apr 23, 2015 | Hospira Inc. The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits. Terminated |
MEA | K042800 |
| Apr 23, 2015 | Hospira Inc. The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits. Terminated |
MEA | K043256 |
| Feb 23, 2015 | Hospira Inc. The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t Terminated |
FRN | K052052 |
| Feb 23, 2015 | Hospira Inc. The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t Terminated |
FRN | K081412 |
| Feb 23, 2015 | Hospira Inc. The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t Terminated |
FRN | K042081 |
| Feb 23, 2015 | Hospira Inc. The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t Terminated |
FRN | K070398 |
| Feb 23, 2015 | Hospira Inc. The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t Terminated |
FRN | K011442 |
| Feb 4, 2015 | Hospira Inc. Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and Terminated |
FRN | K042081 |
| Nov 24, 2014 | Hospira Inc. GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088.
Product Usage
The pump is suitable for intravenous, arterial, subcutaneous, short-term Terminated |
FRN | K060806 |
| Nov 24, 2014 | Hospira Inc. GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150.
Product Usage
The pump is suitable for intravenous, arterial, subcutaneous, short-term Terminated |
FRN | K060806 |
| Oct 24, 2014 | Hospira Inc. The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 Terminated |
FRN | K060806 |
| Oct 24, 2014 | Hospira Inc. The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 Terminated |
FRN | K060806 |
| Jul 10, 2014 | Hospira Inc. The Hospira MedNet Medication Management Suite (MMS).
Product Usage:
The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible comp Terminated |
FRN | K042609 |
| Jul 10, 2014 | Hospira Inc. GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and Terminated |
FRN | K060806 |
| Jun 3, 2014 | Hospira Inc. Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and paren Terminated |
FRN | K952799 |
| Jun 3, 2014 | Hospira Inc. Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general Terminated |
FRN | K010924 |
| Jun 3, 2014 | Hospira Inc. LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration. Terminated |
FRN | K911401 |
| May 16, 2014 | Hospira Inc. LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira
Prod Terminated |
GBX | K841362 |
| May 16, 2014 | Hospira Inc. LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira
Product Usage:
For Use With Flexible Irriga Terminated |
GBX | None listed |
| May 16, 2014 | Hospira Inc. LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira
Produc Terminated |
LJH | None listed |
| May 16, 2014 | Hospira Inc. LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira
Product Usage:
For us Terminated |
GBX | None listed |
| May 16, 2014 | Hospira Inc. LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira
Pr Terminated |
LJH | None listed |
| May 1, 2014 | Hospira Inc. GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosti Terminated |
FRN | K060806 |
| May 1, 2014 | Hospira Inc. Hospira Acclaim Encore Infusion Pump
Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration se Terminated |
FRN | K011096 |
| May 1, 2014 | Hospira Inc. Abbott Acclaim Infusion Pump
Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fl Terminated |
FRN | K991501 |
| Apr 21, 2014 | Hospira Inc. LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette.
For administration of blood and blood bags for use Terminated |
FRN | K982159 |
| Mar 6, 2014 | Hospira Inc. *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Terminated |
FPA | K101677 |
| Dec 6, 2013 | Hospira Inc. Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA.
Used to isolate suction waste during surge Terminated |
GCX | None listed |
| Nov 21, 2013 | Hospira Inc. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered Terminated |
FRN | K083019 |
| Nov 21, 2013 | Hospira Inc. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered Terminated |
FRN | K060806 |
| Nov 20, 2013 | Hospira Inc. *** 1) SYMBIQ One-Channel Infuser;
*** 2) SYMBIQ Two-Channel Infuser;
*** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along Terminated |
FRN | K110901 |
| Nov 14, 2013 | Hospira Inc. The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Inf Terminated |
FRN | K042081 |
| Nov 14, 2013 | Hospira Inc. The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 I Terminated |
FRN | K042081 |
| Nov 14, 2013 | Hospira Inc. The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 I Terminated |
FRN | K052052 |
| Nov 14, 2013 | Hospira Inc. The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Inf Terminated |
FRN | K070398 |
| Nov 14, 2013 | Hospira Inc. The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 I Terminated |
FRN | K021350 |
| Nov 14, 2013 | Hospira Inc. The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Inf Terminated |
FRN | K982159 |
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