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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-2608-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25;
b) NEONATAL TRACHEOSTOMY TUBE 3.0mm T...
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1
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08/23/2024
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FEI # 3012307300 Smiths Medical ASD Inc.
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Z-2609-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25;
b) NEONATAL TRACHEOSTOMY TUB...
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1
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08/23/2024
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FEI # 3012307300 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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FEI # 3012307300 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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FEI # 3012307300 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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FEI # 3012307300 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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FEI # 3012307300 Smiths Medical ASD Inc.
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Z-2589-2024 - PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160;
b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/...
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1
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08/23/2024
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FEI # 3012307300 Smiths Medical ASD Inc.
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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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FEI # 3012307300 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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FEI # 3012307300 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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FEI # 3012307300 Smiths Medical ASD Inc.
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