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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-2614-2024 - a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25;
b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Num...
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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-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-2610-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025;
b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P...
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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-2606-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025;
b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67...
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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-2612-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40;
b) PEDIATRIC TRACHEOSTO...
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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-2613-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25;
b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TT...
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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-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-2599-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25;
b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDA...
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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-2604-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025;
b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , 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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