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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-2598-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40;
b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGH...
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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-2600-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Product Code/List Number/Item Code 60PFSS25
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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-2601-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30;
b) 3.5MM FLEXTEND PEDIATRIC STANDARD...
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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-2602-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025;
b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product...
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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-2603-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025;
b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code...
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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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Z-2605-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025;
3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product 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-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-2607-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
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1
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08/23/2024
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Smiths Medical ASD Inc.
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