Angiodynamics Navilyst Medical recalls
Angiodynamics Navilyst Medical appears in 78 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- 5F DL BIOFLO PASV, Catalog Number 60M141006
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS 5F DL BIOFLO PASV, Catalog Number 60M161567
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems
FDA Device · Class II · 2018-04-25 · Angiodynamics Navilyst Medical
Reason: NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure. - Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The X…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical
Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, th… - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Tech…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical
Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, th… - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Tech…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical
Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, th… - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883 The Xcela with PASV, BioFlo PICC with ENDEXO Technology,…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical
Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, th… - XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 The Xcela with PASV, BioFlo PICC with ENDEXO Technolog…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical
Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, th… - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Tech…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical
Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, th… - XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical
Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, th… - Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-818 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical
Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, th… - Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 The Xcela with PASV, BioFlo PICC with ENDEXO Techno…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical
Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, th… - XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog No. 45-732 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical
Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, th… - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology,…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical
Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, th… - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology,…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical
Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, th… - Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical
Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, th… - NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
FDA Device · Class II · 2017-04-26 · Angiodynamics Navilyst Medical
Reason: The product has the potential to be non-sterile as it was not packaged in accordance to specification. - Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431,…
FDA Device · Class II · 2017-02-15 · Angiodynamics Navilyst Medical
Reason: The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may result in the device not properly… - Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a N…
FDA Device · Class II · 2016-12-14 · Angiodynamics Navilyst Medical
Reason: Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst con… - BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:50…
FDA Device · Class II · 2016-12-14 · Angiodynamics Navilyst Medical
Reason: Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst con… - Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenien…
FDA Device · Class II · 2016-12-14 · Angiodynamics Navilyst Medical
Reason: There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may cont… - BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with EN…
FDA Device · Class II · 2016-12-14 · Angiodynamics Navilyst Medical
Reason: Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst con… - Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenien…
FDA Device · Class II · 2016-12-14 · Angiodynamics Navilyst Medical
Reason: There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may cont… - AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and…
FDA Device · Class II · 2016-06-01 · Angiodynamics Navilyst Medical
Reason: Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow C… - Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are d…
FDA Device · Class II · 2016-06-01 · Angiodynamics Navilyst Medical
Reason: Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow C…