Class II — Bioseal Corporation
| Recalling firm | BIOSEAL |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Completed |
| 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. |
| Product | Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096 |
| Quantity | 580 units |
| Distribution | US: IL and MO OUS: None |
| Initiated | 2021-03-23 |
| Classified | 2021-05-20 |
| Recall number | Z-1624-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bioseal Corporation (Z-1624-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87636/
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