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FDA medical-device recall record: Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Numbe...

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FDA medical-device recall record: Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Numbe...

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Class II record with ongoing status. Recalling firm: Medline Industries, LP. Reason: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier...

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Class II record with ongoing status. Recalling firm: Medline Industries, LP. Reason: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier...

Filed automatically from openFDA Device Enforcement Reports because the published record is itself the fact. This entry reproduces what the source stated and links it; it adds no analysis, and nothing in it is inferred.

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