NxStage Medical, Inc. - Premixed Dialysate for Hemodialysis - Class 2 Recall
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2018 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - NaturaLyte Liquid Acid - Class 2 Recall
NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 15, 2018 Category: Medical Devices Source Type: alerts
NxStage Medical, Inc. - Subsystem, proportioning - Class 2 Recall
NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 Hemodialysis systems and accessories (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 2, 2018 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - 2008T Hemodialysis Delivery System - Class 2 Recall
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts
Arrow International Inc - ARROWgard Blue - Class 2 Recall
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts
Arrow International Inc - ARROWgard Blue YouBlend TwoLumen Hemodialysis Catheterization Kit for High Volume Infusions - Class 2 Recall
1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavia, or femoral veins Catheter, hemodialysis non-implanted (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 13, 2017 Category: Medical Devices Source Type: alerts
Arrow International Inc - ARROWgard Blue YouBend TwoLumen Hemodialysis Catheterization Kit - Class 2 Recall
ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple periph...
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts
Arrow International Inc - TwoLumen Hemodialysis Catheterization Kit - Class 2 Recall
Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressu...
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts
Arrow International Inc - ARROWgard Blue YouBend TwoLumen Hemodialysis Catheterization Kit - Class 2 Recall
ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple periph...
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts
Arrow International Inc - TwoLumen Central Venuous Access Kit - Class 2 Recall
Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter...
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts
Mesa Laboratories, Inc. - Conductivity/TDS Calibrator Solution - Class 2 Recall
MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. T...
Source: Medical Device Recalls - May 17, 2017 Category: Medical Devices Source Type: alerts
Cardiovascular Systems Inc - ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire - Class 2 Recall
ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a ...
Source: Medical Device Recalls - April 11, 2017 Category: Medical Equipment Source Type: alerts
Molded Products Inc - NonSterile Double DIN to DIN Y Connector - Class 2 Recall
Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2017 Category: Medical Equipment Source Type: alerts
Merit Medical Systems, Inc. - 7F Prelude Short Sheath Introducer - Class 1 Recall
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access. (Sou...
Source: Medical Device Recalls - March 25, 2017 Category: Medical Equipment Source Type: alerts
Cardiovascular Systems Inc - DIAMONDBACK 360 Peripheral Orbital Atherectomy System - Class 2 Recall
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs The DIAMONDBACK 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as th...
Source: Medical Device Recalls - February 23, 2017 Category: Medical Equipment Source Type: alerts
