September 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
September 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC32
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
September 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls See RES description
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
September 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
September 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls See RES description
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
September 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls See RES Description
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
September 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls see RES for description
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
September 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2)
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/L
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDI
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Produ
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANG
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Cod
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANG
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Pro
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Cod
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List N
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List N
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Pro
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH N
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Produ
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/Li
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/Li
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List N
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List
Hazard: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.