thejoe Hospira Inc.

Hospira Inc.: 108 FDA recall reports

Every medical device recall the FDA has published for Hospira Inc.. The fault, and how the agency graded it.

108Reports

27Class I

0Ongoing

2017-01-18Most recent

27 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	81
Class I	27

By year reported

Year	Reports
2012	8
2013	39
2014	19
2015	8
2016	33
2017	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administrat

Z-1016-2017 · Class II · reported 2017-01-18 · Terminated

Why it was recalled: 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.
Product: 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.
Where it went: Nationwide Distribution
How much: 48,050 units

Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16

Z-0362-2017 · Class II · reported 2016-11-16 · Terminated

Why it was recalled: 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.
Product: Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
Where it went: Worldwide Distribution - US (nationwide) and Canada
How much: 10897

Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16

Z-0361-2017 · Class II · reported 2016-11-16 · Terminated

Why it was recalled: 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.
Product: Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
Where it went: Worldwide Distribution - US (nationwide) and Canada
How much: 10,337

Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Nu

Z-0354-2017 · Class II · reported 2016-11-09 · Terminated

Why it was recalled: 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.
Product: Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
Where it went: Nationwide Distribution and Canada
How much: 15,285

Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Nu

Z-0353-2017 · Class II · reported 2016-11-09 · Terminated

Why it was recalled: 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.
Product: Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
Where it went: Nationwide Distribution and Canada
How much: 20,311

Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a gen

Z-0306-2017 · Class II · reported 2016-11-02 · Terminated

Why it was recalled: 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.
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; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.
Where it went: Worldwide Distribution - USA (nationwide) and Canada
How much: 35,596 devices in total

Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a g

Z-0305-2017 · Class II · reported 2016-11-02 · Terminated

Why it was recalled: 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.
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; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.
Where it went: Worldwide Distribution - USA (nationwide) and Canada
How much: 35,596 devices in total

LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinicia

Z-2873-2016 · Class II · reported 2016-09-28 · Terminated

Why it was recalled: 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.
Product: LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.
Where it went: United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.
How much: 8,794

LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of

Z-2874-2016 · Class II · reported 2016-09-28 · Terminated

Why it was recalled: 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.
Product: LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
Where it went: United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.
How much: 69

Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices

Z-2729-2016 · Class II · reported 2016-09-14 · Terminated

Why it was recalled: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Product: 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 clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Where it went: United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
How much: 357,778 total

Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family

Z-2722-2016 · Class II · reported 2016-09-14 · Terminated

Why it was recalled: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Product: 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 spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Where it went: United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
How much: 357,778 total

Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices

Z-2723-2016 · Class II · reported 2016-09-14 · Terminated

Why it was recalled: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Product: 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 clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Where it went: United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
How much: 357,778 total

Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a mul

Z-2727-2016 · Class II · reported 2016-09-14 · Terminated

Why it was recalled: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Product: 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 the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Where it went: United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
How much: 357,778 total

Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a mu

Z-2730-2016 · Class II · reported 2016-09-14 · Terminated

Why it was recalled: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Product: 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 the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Where it went: United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
How much: 357,778 total

Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices

Z-2725-2016 · Class II · reported 2016-09-14 · Terminated

Why it was recalled: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Product: 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 clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Where it went: United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
How much: 357,778 total

Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices

Z-2724-2016 · Class II · reported 2016-09-14 · Terminated

Why it was recalled: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Product: 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 clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Where it went: United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
How much: 357,778 total

Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of

Z-2728-2016 · Class II · reported 2016-09-14 · Terminated

Why it was recalled: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Product: 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 of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Where it went: United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
How much: 357,778 total

Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a mul

Z-2726-2016 · Class II · reported 2016-09-14 · Terminated

Why it was recalled: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Product: 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 the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Where it went: United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
How much: 357,778 total

Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 4

Z-2594-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: 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.
Product: Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 43025-01; 4) List Number 43025-11; 5) List Number 43025-21; 6) List Number 43025-25; 7) List Number 43038-05; 8) List Number 43043-01; 9) List Number 43044-01; 10) List Number 43044-11; 11) List Number 43046-01; 12) List Number 43047-01; 13) List Number 43041-01; 14) List Number 43024-01; 15) List Number 43027-01; 16) List Number 43027-14; 17) List Number 43001-01; 18) List Number 43064-01; 19) List Number 43046-05; 20) List Number 43042-11; 21) List Number 43042-01; 22) List Number 43044-05; 23) List Number 43044-15
Where it went: *** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY), District of Columbia, Puerto Rico; *** FOREIGN: Australia, Canada, Costa Rica, Singapore, South Africa
How much: 67,410,861 liners and 67,410,861 lids/canisters in total

Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000, with Valve 1) List

Z-2593-2016 · Class II · reported 2016-08-24 · Terminated

Why it was recalled: 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.
Product: Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000, with Valve 1) List Numbers 43449-01 and 43449-11; LIST NO. 43449 RECEPTAL CANISTER; CANISTER FOR REUSE, THROW AWAY LINER ONLY; DO NOT FILL 900 ABOVE LINE 2) List Numbers 43423-01 and 43423-21; LIST NO. 43423; RECEPTAL CANISTER; CANISTER FOR REUSE; THROW AWAY LINER ONLY; 1400. 3) List Numbers 43445-01 and 43445-11; LIST NO. 43445; RECEPTAL CANISTER; CANISTER FOR REUSE; THROW AWAY LINER ONLY; DO NOT FILL 1900 ABOVE THIS LINE. 4) List Number 43496-01.
Where it went: *** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY), District of Columbia, Puerto Rico; *** FOREIGN: Australia, Canada, Costa Rica, Singapore, South Africa
How much: 67,410,861 liners and 67,410,861 lids/canisters in total

The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients

Z-2139-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: 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.
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, oncology centers, and medical/surgical nursing units.
Where it went: Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + Virgin Islands; *** FOREIGN:
How much: 53,151 infusion pump systems

The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor

Z-2140-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: 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.
Product: The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3 infusion pump allows clinicians to administer or patients to self-administer analgesia safely and effectively within clinician programmed limits. The epidural route can be used to provide anesthesia or analgesia.
Where it went: Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + Virgin Islands; *** FOREIGN:
How much: 8,216 infusion pump systems

The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled ana

Z-2142-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: 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.
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 Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.
Where it went: Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + Virgin Islands; *** FOREIGN:
How much: 6,268 infusion pump systems

LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self

Z-2141-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: 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.
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 wide range of clinical settings that includes but is not limited to the following: medical, laboratory/delivery/post-partum, burn unit, surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), pediatrics.
Where it went: Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + Virgin Islands; *** FOREIGN:
How much: 38,878 infusion pump systems

Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a gen

Z-2055-2016 · Class II · reported 2016-07-06 · Terminated

Why it was recalled: 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.
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; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.
Where it went: Worldwide Distribution - USA (nationwide)
How much: 20,311

*** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FIL

Z-2061-2016 · Class II · reported 2016-07-06 · Terminated

Why it was recalled: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
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-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
Where it went: US (Nationwide) Distribution
How much: 3,920,932 units in total

*** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE P

Z-2062-2016 · Class II · reported 2016-07-06 · Terminated

Why it was recalled: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
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; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; *** 3) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; *** 4) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: *** 5) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; *** 6) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP;...
Where it went: US (Nationwide) Distribution
How much: 3,920,932 units in total

*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE

Z-2058-2016 · Class II · reported 2016-07-06 · Terminated

Why it was recalled: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
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 Inch, Non-DEHP; *** 3) Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Site; 103 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 infusion. It is normally used with a syringe or a secondary IV infusion set.
Where it went: US (Nationwide) Distribution
How much: 1) 941,982 units; 2) 1,200 units; 3) 4,449,939 units

*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAV

Z-2059-2016 · Class II · reported 2016-07-06 · Terminated

Why it was recalled: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
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 PLUMSET, NONVENTED WITH 210 MICRON FILTER AND OPTION-LOK, DUAL CHANNEL, CLAVE SECONDARY PORT; NOMINAL LENGTH: 102 IN (260 CM); PRIMING VOLUME: 69 ML; *** 3) Product labeled in part: 14954-28; LIFESHIELD; LIFECARE 5000 WITH PROXIMAL 0.2 MICRON FILTER-0L, CONVERTIBLE PIN, DUAL CHANNEL, INTEGRAL Y CLAVE, NON-DEHP; NOMINAL LENGTH: 112 IN (284 CM); PRIMING VOLUME: 24 ML; *** 4) Product labeled in part: List No. 19553-12; LifeShield; LATEX-FREE; PLUM EXTENSION SET WITH CLAVE SECONDARY PORT; NOMINAL LENGTH: 28 IN (71 CM); PRIMING VOLUME: 7.1 ML; SET CONTAINS DEHP; *** 5) Product labeled in part: 19556-28; LIFESHIELD; PLUMSET HEMOSET 100 ML BURETTE, DUAL CHANNEL CASSETTE WITH CLAVE, SECURE LOCK, NON-DEHP NOMINAL LENGTH: 98 IN (249 CM); PRIMING VOLUME: 17 ML; *** 6) Product labeled in part: 19557-28; LIFESHIELD; PLUMSET CONVERTIBLE PIN, TWO INTEGRAL CLAVES, CLAVE SECONDARY PORT AND OPTION LOK, NON-DEHP; NOMINAL...
Where it went: US (Nationwide) Distribution
How much: 1) 65,904 units; 2) 270,321 units; 3) 32,088 units; 4) 4,944 units; 5) 14,064 units; 6) 503,328 units; 7) 7,560 units

*** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE

Z-2060-2016 · Class II · reported 2016-07-06 · Terminated

Why it was recalled: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
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 infusion. It is normally used with a syringe or a secondary IV infusion set.
Where it went: US (Nationwide) Distribution
How much: 3,920,932 units in total

Showing the 30 most recent of 108. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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