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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1624-2021 |
Event ID | 87636 |
Event Description | Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096 |
Product Type | Devices |
Distribution | US: IL and MO OUS: None |
Quantity | 580 units |
Recall Reason | 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. |
Device Classification | 20210526 |
Device Code Info | Affected Lot Numbers: 400521, 400514, 400551, 400556, 400551, 400541, 400536, 400536, 400536 400536, 400536, 400556, 400558 |
Center Classification Date | 20210520 |
Recall Initiation Date | 20210323 |
Recalling Firm | Bioseal Corporation |
Initial Notification | |
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