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 | |
| Similar To |