medical Class II Updated 2021-05-26

Bioseal Corporation recalls Bioseal, Central Line Dressing Kit, containing ChloraPREP Ap

Recalled Product

Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157

Hazard / Issue

Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.

Issued by

FDA

Affected States: IL, MO
Lot/Code Info: Affected Lot Numbers: 400530 400528, 400536, 400537, 400514, 400522, 400514, 400514, 400522, 400514, 400569, 400569, 400565, 400569, 400565, 400556, 400556, 400556, 400540, 400562, 400537, 400530, 400537, 400530, 400537
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