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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-2278-2021 - Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI...
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2
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08/12/2021
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Edwards Lifesciences, LLC
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Z-2279-2021 - Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI:...
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2
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08/12/2021
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Edwards Lifesciences, LLC
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Z-2283-2021 - Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501
*NOT DISTRIBUTED WITHIN THE US
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2
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08/12/2021
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Edwards Lifesciences, LLC
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Z-2281-2021 - Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO,...
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2
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08/12/2021
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Edwards Lifesciences, LLC
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Z-2282-2021 - Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01...
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2
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08/12/2021
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Edwards Lifesciences, LLC
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Z-2280-2021 - Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495
*NOT DISTRIBUTED WITHIN THE US
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2
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08/12/2021
|
Edwards Lifesciences, LLC
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