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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-2588-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170;
b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT ...
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1
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08/23/2024
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Smiths Medical ASD Inc.
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Z-2615-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025;
b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE ,...
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1
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08/23/2024
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Smiths Medical ASD Inc.
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Z-2590-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
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1
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08/23/2024
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Smiths Medical ASD Inc.
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Z-2591-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030;
b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035;
c...
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1
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08/23/2024
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Smiths Medical ASD Inc.
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Z-2592-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25;
b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS...
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1
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08/23/2024
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Smiths Medical ASD Inc.
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Z-2593-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
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1
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08/23/2024
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Smiths Medical ASD Inc.
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Z-2594-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30;
b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Produ...
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1
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08/23/2024
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Smiths Medical ASD Inc.
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Z-2595-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025;
b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Co...
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1
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08/23/2024
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Smiths Medical ASD Inc.
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Z-2596-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40;
b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, P...
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1
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08/23/2024
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Smiths Medical ASD Inc.
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Z-2597-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
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1
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08/23/2024
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Smiths Medical ASD Inc.
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