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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 - ARROWgard Blue(R) MAC(TM) TwoLumen Central Venous Access Kit - Class 2 Recall
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters 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-related infections for this device. It is not intended to be used as a treatme...
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts

Arrow International Inc - ARROWgard Blue PLUS(R) TwoLumen Central Venous Catherization Kit - Class 2 Recall
ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts

Arrow International Inc - Arrowgard Blue (R) Access Device - Class 2 Recall
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 -8 Fr. Catheters. 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 surfac...
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts

Arrow International Inc - Pressure Injectable MultiLumen Central Venous Catheterization Kit - Class 2 Recall
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: 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 mo...
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 - Arrow VPS Access Kit - Class 2 Recall
Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts

Arrow International Inc - Arrow Pressure Injectable PICC Kit - Class 2 Recall
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts

Arrow International Inc - Pressure Injectable MultiLumen Central Venous Catheterization Kit - Class 2 Recall
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: 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; replac...
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts

Arrow International Inc - Pressure Injectable ARROW(R) PICC Kit - Class 2 Recall
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the An-owEVOLUTIONTM Pressure Injectable P1CC may not exceed 300 psi. Chlorag+ard Technology treatment on the external surface of the catheter body as well as th...
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts

Arrow International Inc - Arrow VPS Access Kit - Class 2 Recall
Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 27, 2017 Category: Medical Devices Source Type: alerts

Arrow International Inc - Arrow gard Blue PLUS Central Venous Catheter - Class 2 Recall
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 11, 2017 Category: Medical Equipment Source Type: alerts

Arrow International Inc - Access Tray - Class 2 Recall
Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 23, 2017 Category: Medical Equipment Source Type: alerts

Bard Access Systems - StatLock PICC Plus Crescent Foam - Class 2 Recall
StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock¿ PICC Plus and StatLock¿ CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts