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...
Reason: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Z-2729-2016September 14, 2016Lake Forest, IL
WalkMed Infusion, LLC
Class IITerminated
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Soft...
Z-2220-2016July 27, 2016Englewood, CO
WalkMed Infusion, LLC
Class IITerminated
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Soft...
Z-2219-2016July 27, 2016Englewood, CO
Hospira Inc.
Class IITerminated
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, crit...
Reason: 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 (t...
Z-2140-2016July 20, 2016Lake Forest, IL
Hospira Inc.
Class IITerminated
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...
Reason: 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 (t...
Z-2139-2016July 20, 2016Lake Forest, IL
Hospira Inc.
Class IITerminated
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, nut...
Reason: 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 th...
Z-2055-2016July 6, 2016Lake Forest, IL
Hospira Inc.
Class IITerminated
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, nut...
Reason: 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 th...
Z-2056-2016July 6, 2016Lake Forest, IL
CareFusion 303, Inc.
Class IITerminated
Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
Reason: CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).
Z-1239-2016March 30, 2016San Diego, CA
Hospira Inc.
Class IITerminated
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...
Reason: Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad.
Z-0863-2016March 2, 2016Lake Forest, IL
MOOG Medical Devices Group
Class IITerminated
Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps. Curlin 4000, catalog number 340; Curlin 6000, 600...
Reason: Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to cali...
Z-0688-2016February 17, 2016Salt Lake City, UT
Bayer Healthcare
Class IITerminated
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
Reason: The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the d...
Z-0627-2016January 20, 2016Indianola, PA
WalkMed Infusion, LLC
Class IITerminated
Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.
Reason: The device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector a...
Z-0242-2016November 18, 2015Englewood, CO
Elite Biomedical Solutions LLC
Class ITerminated
Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 81...
Reason: Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Z-2372-2015August 26, 2015Cincinnati, OH
Elite Biomedical Solutions LLC
Class ITerminated
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 81...
Reason: Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Z-2371-2015August 26, 2015Cincinnati, OH
Unomedical As
Class IITerminated
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
Reason: Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
Z-1821-2015July 1, 2015Roskilde
CareFusion 303, Inc.
Class IITerminated
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The softwa...
Reason: An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospit...
Z-1811-2015June 24, 2015San Diego, CA
Smiths Medical ASD, Inc.
Class IITerminated
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient ...
Reason: Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some CADD¿-Solis pumps. Binding of the Cassette/ Keypad Lock can ...
Z-1813-2015June 24, 2015Saint Paul, MN
Roche Diabetes Care, Inc.
Class IITerminated
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Reason: Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pum...
Z-1733-2015June 17, 2015Indianapolis, IN
Roche Diabetes Care, Inc.
Class IITerminated
AccuChek Spirit insulin infusion pump.
Reason: Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pum...
Z-1734-2015June 17, 2015Indianapolis, IN
Medtronic Neuromodulation
Class IITerminated
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system t...
Reason: Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function.
Z-1681-2015June 3, 2015Minneapolis, MN
Hospira Inc.
Class IITerminated
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.
Reason: 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.
Z-1518-2015April 29, 2015Lake Forest, IL
Hospira Inc.
Class IITerminated
The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
Reason: 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.
Z-1517-2015April 29, 2015Lake Forest, IL
Baxter Healthcare Corp
Class IITerminated
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with M...
Reason: Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the near...
Z-1451-2015April 22, 2015Deerfield, IL
CareFusion 303, Inc.
Class IITerminated
Alaris PC units, Model No. 8015. Infusion pump.
Reason: CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue.
Z-1311-2015April 1, 2015San Diego, CA
Hospira Inc.
Class ITerminated
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...
Reason: One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.