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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-0297-2025 - Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
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1
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11/12/2024
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Boston Scientific Corporation
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Z-0298-2025 - Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
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1
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11/12/2024
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Boston Scientific Corporation
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Z-0299-2025 - Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
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1
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11/12/2024
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Boston Scientific Corporation
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Z-0303-2025 - Boston Scientific SMARTFREEZE CRYO CONSOLE:
Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Ma...
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1
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11/12/2024
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Boston Scientific Corporation
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Z-0301-2025 - Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
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1
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11/12/2024
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Boston Scientific Corporation
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Z-0302-2025 - Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
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1
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11/12/2024
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Boston Scientific Corporation
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Z-0300-2025 - Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
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1
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11/12/2024
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Boston Scientific Corporation
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