Angiodynamics Inc. (Navilyst Medical Inc.) - Peripherally Inserted Central Catheters (PICC) - Class 2 Recall
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN # H965750355/Catalog No: 5026468 The BioFlo PICCs with ENDEXO Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection o...
Source: Medical Device Recalls - December 6, 2016 Category: Medical Equipment Source Type: alerts
Angiodynamics Inc. (Navilyst Medical Inc.) - Peripherally Inserted Central Catheters (PICC) - Class 2 Recall
Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 6, 2016 Category: Medical Equipment Source Type: alerts
Angiodynamics Inc. (Navilyst Medical Inc.) - Peripherally Inserted Central Catheters (PICC) - Class 2 Recall
BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 6, 2016 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc., an AngioDyamics Company - Xcela PICC with PASV Valve Technology Catheter Kit - Class 2 Recall
Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc., an AngioDyamics Company - Vaxcel PICC with PASV Catheter Kit - Class 2 Recall
Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc., an AngioDyamics Company - Xcela Hybrid PICC with PASV Valve Technology, IR145 Kit - Class 2 Recall
Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc., an AngioDyamics Company - BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST70 Kit - Class 2 Recall
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc., an AngioDyamics Company - BioFlo PICC with ENDEXO and PASV Valve Technology, MST70 Kit - Class 2 Recall
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458930, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc., an AngioDyamics Company - Vaxcel PICC with PASV IR145 Kit - Class 2 Recall
Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc., an AngioDyamics Company - BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR145 Kit - Class 2 Recall
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc., an AngioDyamics Company - Xcela Hybrid PICC with PASV Valve Technology, MST70 Kit - Class 2 Recall
Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc., an AngioDyamics Company - Xcela PICC with PASV Valve Technology, Intermediate MST45 Kit - Class 2 Recall
Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc., an AngioDyamics Company - Xcela PICC with PASV Valve Technology - Class 2 Recall
Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc., an AngioDyamics Company - Vaxcel PICC with PASV Introducer Kit - Class 2 Recall
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc., an AngioDyamics Company - BioFlo PICC with ENDEXO and PASV Valve Technology, MST45 Kit - Class 2 Recall
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
