Fresenius Vial Sa - Volumat MC Agilia - Class 2 Recall
Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV...
Source: Medical Device Recalls - November 2, 2018 Category: Medical Devices Source Type: alerts
Arrow International Inc - ARROWgard Blue Plus MultiLumen CVC Kit - Class 2 Recall
Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack of usable peripheral IV sites, Central venous pressure monitoring, Total parenteral nutrition (TPN), Infusions of fluids, medications, or chemotherapy, and Frequent blood sampling or receiving blood transfusions/blood products. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 27, 2018 Category: Medical Devices Source Type: alerts
Medical Components, Inc dba MedComp - Plastic Dignity Low Profile CT Port - Class 2 Recall
6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 7, 2018 Category: Medical Devices Source Type: alerts
Medical Components, Inc dba MedComp - 9.6F Plastic Dignity MidSized CT port w/PreAttached Silicone Catheter - Class 2 Recall
9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 9, 2017 Category: Medical Equipment Source Type: alerts
Baxter Corporation Englewood - ABACUS - Class 2 Recall
ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2015 Category: Medical Equipment Source Type: alerts
Medical Components, Inc dba MedComp - 9F Plastic Dual Port - Class 2 Recall
9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts
Hospira Inc. - GemStar Docking Station - Class 1 Recall
The GemStar Docking Station is often used in the post-operative setting where the GemStar pump is providing pain/PCA medication infusion, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. In this manner the GemStar pump is often used for epidural delivery. The docking station is also used for hosting the GemStar pump for other general infusions such as IV solutions, antibiotics, parenteral nutrition, cardiovascular, and the typical range of applications which more traditional large volume infusion pumps are used. The GemStar Docking Station is used most often in the hospital...
Source: Medical Device Recalls - May 2, 2014 Category: Medical Equipment Source Type: alerts
WalkMed Infusion, LLC - Triton FP Infusion Pump - Class 2 Recall
Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2014 Category: Medical Equipment Source Type: alerts
Bard Access Systems - Titanium Single Lumen LowProfile port, with PreAttached openEnded Silicone 6.6Fr Catheter. - Class 2 Recall
Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180 Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performe...
Source: Medical Device Recalls - January 24, 2014 Category: Medical Equipment Source Type: alerts
Bard Access Systems - MRI Low Profile Single Lumen port with OpenEnded 6.6Fr Silicone Catheter. - Class 2 Recall
MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percu...
Source: Medical Device Recalls - January 24, 2014 Category: Medical Equipment Source Type: alerts
B Braun Medical, Inc. - Outlook ES Safety Infusion System - Class 1 Recall
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2013 Category: Medical Equipment Source Type: alerts
B Braun Medical, Inc. - Outlook ES Safety Infusion System - Class 2 Recall
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 11, 2013 Category: Medical Equipment Source Type: alerts
B Braun Medical, Inc. - Outlook ES Safety Infusion System - Class 2 Recall
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2013 Category: Medical Equipment Source Type: alerts
