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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-2611-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40;
b) PEDIATRIC 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-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-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-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-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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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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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-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-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-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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