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Hospira, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 1776 NORTH CENTENNIAL DR., MCPHERSON, KS, 67460
Website: pfizer.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(877)946-7747
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1925262
DUNS Number: 141588017

Catalogue (312)

Page 6 of 7

Device	Model / Reference	Registries	Class	Status
Lifeshield	1130101	FDA UDI	Class II	Active
Lifeshield	1428128	FDA UDI	Class II	Active
Plum	1171002	FDA UDI	Class II	Active
Plum	113948	FDA UDI	Class II	Active
Plum	1197902	FDA UDI	Class II	Active
MedNet	6.20.01	FDA UDI	Class II	Active
Lifeshield	1189305	FDA UDI	Class II	Active
Lifeshield	1264248	FDA UDI	Class II	Active
Hospira	1269965	FDA UDI	Class II	Active
Lifeshield	1195501	FDA UDI	Class II	Active
Sapphire	1638502	FDA UDI	Class II	Active
Plum	1424328	FDA UDI	Class II	Active
Plum	1197703	FDA UDI	Class II	Active
Lifeshield	2065328	FDA UDI	Class II	Active
Plum	1424528	FDA UDI	Class II	Active
Lifeshield	1241901	FDA UDI	Class II	Active
Add-Vantage Addaptor	K133602	FDA 510(k)	Class II	Active
Hospira Extension Set, Hospira Primary Set	K161036	FDA 510(k)	Class II	Active
Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter, Non-Dehp	K121032	FDA 510(k)	Class II	Active
Lifecare Pca Infusion System With Hospira Mednet Software	K042800	FDA 510(k)	Class II	Active
Disposable Transpac Iii Integrated Transducer (it)	K052828	FDA 510(k)	Class II	Active
Opticath Central Venous Oximetry Probe With Fluidic Seal With/Without Heparin	K061159	FDA 510(k)	Class II	Active
Hospira Enteral Feeding Set, Model 20640	K061432	FDA 510(k)	Class II	Active
Hospira Administration Sets	K160870	FDA 510(k)	Class II	Active
Infusion Sets	K103344	FDA 510(k)	Class II	Active
Gemstar Sp Infusion System With Gemstar Sp Infusion Suite Software	K083019	FDA 510(k)	Class II	Active
Hospira Plum A+ Infusion Pump System V11.5, Hospira Plum A+ 3 Infusion Pump System, V11.5	K052052	FDA 510(k)	Class II	Active
Transpac Iii Disposable Straight Pressure Transducer And Kit	K061573	FDA 510(k)	Class II	Active
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module	K161469	FDA 510(k)	Class II	Active
Opticath Central Venous Oximetry Catheter	K061585	FDA 510(k)	Class II	Active
Lifeshield Vision Infusion Set With Pre-Pierced Reseal	K113683	FDA 510(k)	Class II	Active
Hospira Primary Sets	K143015	FDA 510(k)	Class II	Active
Symbiq Infusion And Adminstration Set	K110901	FDA 510(k)	Class II	Active
Hospira Infusion Blood Sets	K101677	FDA 510(k)	Class II	Active
Hospira Latex-Free Critical Care And Advanced Sensor Catheters	K091268	FDA 510(k)	Class II	Active
Hospira Blood Set	K143087	FDA 510(k)	Class II	Active
Plum A+ Hyperbaric Infusion System With Hospira Mednet Software	K081412	FDA 510(k)	Class II	Active
Hospira Plum A+ Infusion Pump, Model 12391	K070398	FDA 510(k)	Class II	Active
IV Administration	K142622	FDA 510(k)	Class II	Active
Flush Syringe Filled With 0.9% Sodium Chloride	K090882	FDA 510(k)	Class II	Active
Hospira Vital Signs Wireless Monitoring System	K090610	FDA 510(k)	Class II	Active
Extension Sets	K142974	FDA 510(k)	Class II	Active
Lifeshield Latex-Free Microbore Extension Set, Model 14949 And Others	K052722	FDA 510(k)	Class II	Active
Plum 360 Infusion System With Hospira Mednet, Smart Card Plug N Play Ce 3.0 Module For Plum A+ Infusion System Upgrade	K141789	FDA 510(k)	Class II	Active
Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model 13088	K060806	FDA 510(k)	Class II	Active
Hospira Mednet Medication Management Suite	K042609	FDA 510(k)	Class II	Active
Lifeshield Latex-Free Gravitech Flow Controller I.v. Sets, Models 17528, 17527, 17525 & 17526	K063239	FDA 510(k)	Class II	Active
Plum A+ Infusion System With Hospira Mednet Software , And Plum A+3 Infusion System With Hospira Mednet Software	K042081	FDA 510(k)	Class II	Active
Hospira Plum Infusion Set; Hospira Infusion Set With Yellow Stripe Tubing	K103224	FDA 510(k)	Class II	Active
Hospira Sapphire Sets	K160492	FDA 510(k)	Class II	Active

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 25, 2016	Z-1833-2016	—	terminated	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.
Mar 25, 2016	Z-1832-2016	—	terminated	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.
Dec 22, 2015	Z-0863-2016	—	terminated	Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad.
Jul 2, 2014	Z-1075-2015	—	terminated	One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Jul 2, 2014	Z-1072-2015	—	terminated	One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Jul 2, 2014	Z-1074-2015	—	terminated	One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Jul 2, 2014	Z-1071-2015	—	terminated	One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Jul 2, 2014	Z-1073-2015	—	terminated	One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
Jun 11, 2014	Z-1050-2015	—	terminated	Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the pole clamp assembly is cracked, the infuser cannot be attached to the IV pole since the knob is used to tighten and loosen the grip of the pole clamp to the pole.
Jun 6, 2014	Z-2027-2014	—	terminated	Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg/min" and "milliUnits/min" are not sent to a Plum A+ device (Version 13.40, 13.41, and 13.4.2) via Auto Programming when those dosing units are not properly established in the customized drug library. A dosing unit mismatch of "nanog/kg/min" or "milliUnits/min" on an unmatched medication will produce a
Mar 25, 2014	Z-1625-2014	—	terminated	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
Mar 25, 2014	Z-1623-2014	—	terminated	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
Mar 25, 2014	Z-1626-2014	—	terminated	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
Mar 25, 2014	Z-1624-2014	—	terminated	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
Mar 25, 2014	Z-1627-2014	—	terminated	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
Feb 25, 2014	Z-1479-2014	—	terminated	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.
Feb 18, 2014	Z-1512-2014	—	terminated	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.
Feb 3, 2014	Z-0096-2015	—	terminated	The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.
Feb 3, 2014	Z-0095-2015	—	terminated	The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.
Jan 31, 2014	Z-2031-2014	—	terminated	The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result in a Beeper Error ("code 10/001/000"). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.
Jan 24, 2014	Z-1703-2014	—	terminated	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
Jan 24, 2014	Z-1702-2014	—	terminated	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
Jan 24, 2014	Z-1704-2014	—	terminated	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
Oct 31, 2013	Z-1483-2014	—	terminated	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.
Oct 31, 2013	Z-1482-2014	—	terminated	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.
Oct 25, 2013	Z-1126-2014	—	terminated	Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly.
Sep 10, 2013	Z-2593-2016	—	terminated	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.
Sep 10, 2013	Z-2594-2016	—	terminated	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.
Sep 9, 2013	Z-2062-2016	—	terminated	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Sep 9, 2013	Z-2059-2016	—	terminated	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Sep 9, 2013	Z-2060-2016	—	terminated	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Sep 9, 2013	Z-2061-2016	—	terminated	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Sep 9, 2013	Z-2058-2016	—	terminated	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Aug 28, 2013	Z-0372-2014	—	terminated	Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers.
Jul 17, 2013	Z-0457-2014	—	terminated	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.
Jun 18, 2013	Z-1751-2013	—	terminated	Hospira has received reports of customers experiencing air-in-line alarms related to administration sets that have a drip chamber with a ball valve. Preliminary investigation findings found that there is a potential for the ball valve to not seal the drip chamber as intended, leading to air in the line of the administration set.
Apr 1, 2013	Z-1856-2013	—	terminated	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Apr 1, 2013	Z-1852-2013	—	terminated	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Apr 1, 2013	Z-1851-2013	—	terminated	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Apr 1, 2013	Z-1858-2013	—	terminated	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Apr 1, 2013	Z-1855-2013	—	terminated	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Apr 1, 2013	Z-1854-2013	—	terminated	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Apr 1, 2013	Z-1853-2013	—	terminated	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Apr 1, 2013	Z-1850-2013	—	terminated	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Apr 1, 2013	Z-1857-2013	—	terminated	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Mar 21, 2013	Z-1117-2013	—	terminated	During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Mar 21, 2013	Z-1116-2013	—	terminated	During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Mar 19, 2013	Z-0421-2015	—	terminated	Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their doctors. Patients are obtaining access to these codes via website sponsors by downloading the GemStar User/Service Manual featured on the sponsors' websites. The GemStar User/Service Manual should be removed from these w
Mar 19, 2013	Z-0422-2015	—	terminated	Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their doctors. Patients are obtaining access to these codes via website sponsors by downloading the GemStar User/Service Manual featured on the sponsors' websites. The GemStar User/Service Manual should be removed from these w
Mar 18, 2013	Z-1159-2013	—	terminated	Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
Mar 18, 2013	Z-1160-2013	—	terminated	Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
Mar 18, 2013	Z-1170-2013	—	terminated	Pump shutting off during use without warning.
Mar 18, 2013	Z-1169-2013	—	terminated	Pump shutting off during use without warning.
Mar 15, 2013	Z-0349-2014	—	terminated	The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion: 1) Cassette Check - D; 2) Cassette Check - P; 3) Proximal Occlusion; 4) Distal Occlusion; 5) Pressure Calibration Error; 6) Bad Pressure Sensor Event; 7) Bad Pressure State; 8) Distal Pressure is Out of Range; 9) Proximal Sensor is Out of Range. A pump with this issue may, instead of reporting an error, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.
Mar 15, 2013	Z-0350-2014	—	terminated	The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion: 1) Cassette Check - D; 2) Cassette Check - P; 3) Proximal Occlusion; 4) Distal Occlusion; 5) Pressure Calibration Error; 6) Bad Pressure Sensor Event; 7) Bad Pressure State; 8) Distal Pressure is Out of Range; 9) Proximal Sensor is Out of Range. A pump with this issue may, instead of reporting an error, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.
Mar 8, 2013	Z-2140-2016	—	terminated	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.
Mar 8, 2013	Z-2142-2016	—	terminated	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.
Mar 8, 2013	Z-2141-2016	—	terminated	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.
Mar 8, 2013	Z-2139-2016	—	terminated	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.
Mar 8, 2013	Z-2874-2016	—	terminated	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.
Mar 8, 2013	Z-2873-2016	—	terminated	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.
Feb 27, 2013	Z-1517-2015	—	terminated	The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
Feb 27, 2013	Z-1518-2015	—	terminated	The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
Feb 19, 2013	Z-1016-2017	—	terminated	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.
Feb 6, 2013	Z-2726-2016	—	terminated	The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Feb 6, 2013	Z-2729-2016	—	terminated	The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Feb 6, 2013	Z-2730-2016	—	terminated	The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Feb 6, 2013	Z-2727-2016	—	terminated	The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Feb 6, 2013	Z-2722-2016	—	terminated	The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Feb 6, 2013	Z-2724-2016	—	terminated	The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Feb 6, 2013	Z-2728-2016	—	terminated	The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Feb 6, 2013	Z-2725-2016	—	terminated	The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Feb 6, 2013	Z-2723-2016	—	terminated	The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Feb 5, 2013	Z-0353-2017	—	terminated	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.
Feb 5, 2013	Z-0354-2017	—	terminated	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.
Feb 4, 2013	Z-2056-2016	—	terminated	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.
Feb 4, 2013	Z-0305-2017	—	terminated	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.
Feb 4, 2013	Z-0306-2017	—	terminated	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.
Feb 4, 2013	Z-2055-2016	—	terminated	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.
Feb 4, 2013	Z-1847-2013	—	terminated	The devices secondary audio signal fails to activate.
Feb 1, 2013	Z-0284-2014	—	terminated	Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken
Feb 1, 2013	Z-0289-2014	—	terminated	Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken
Feb 1, 2013	Z-0288-2014	—	terminated	Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken
Feb 1, 2013	Z-0290-2014	—	terminated	Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken
Feb 1, 2013	Z-0287-2014	—	terminated	Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken
Feb 1, 2013	Z-0286-2014	—	terminated	Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken
Feb 1, 2013	Z-0283-2014	—	terminated	Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken
Feb 1, 2013	Z-0285-2014	—	terminated	Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken
Dec 7, 2012	Z-0626-2013	—	terminated	The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.
Dec 7, 2012	Z-0625-2013	—	terminated	The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.
Dec 7, 2012	Z-0624-2013	—	terminated	The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.
Oct 26, 2012	Z-0483-2013	—	terminated	The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
Oct 26, 2012	Z-0481-2013	—	terminated	The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
Oct 26, 2012	Z-0482-2013	—	terminated	The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
Aug 29, 2012	Z-0070-2013	—	terminated	The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion.
Aug 29, 2012	Z-0069-2013	—	terminated	The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion.
Aug 28, 2012	Z-2395-2012	—	terminated	Embedded iron oxide glass defect which may have the potential to break off into the solution.
Aug 2, 2012	Z-2346-2012	—	terminated	Reports of leaking during filling and administration.
Jul 13, 2012	Z-2075-2012	—	terminated	The float valve in the burette sticks to the burette wall and does not open or close properly.
Apr 25, 2012	Z-1491-2012	—	terminated	The Lifeshield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. A set which results in a cassette test failure alarm may result in delay in therapy, requiring medical intervention.