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Bioseal Corporation Recall 87636

Description: Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096

Bioseal Corporation Recall 87636 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1624-2021
Event ID87636
Event DescriptionBioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Product TypeDevices
DistributionUS: IL and MO OUS: None
Quantity580 units
Recall ReasonPre-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.
Device Classification20210526
Device Code InfoAffected Lot Numbers: 400521, 400514, 400551, 400556, 400551, 400541, 400536, 400536, 400536 400536, 400536, 400556, 400558
Center Classification Date20210520
Recall Initiation Date20210323
Recalling FirmBioseal Corporation
Initial Notification E-Mail
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