Bioseal — Class II medical device recall Z-1622-2021
Completed recall by Bioseal Corporation, reported 2021-05-26, distributed in IL, MO. Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides,
| Recall number | Z-1622-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bioseal Corporation, Placentia, CA, United States |
| Recall initiated | 2021-03-23 |
| Classified | 2021-05-20 |
| Reported by FDA | 2021-05-26 |
| Distributed | IL, MO |
| Quantity | 1,560 units |
| Reason classes | packaging |
| Pathogens | mold |
| UPC / GTIN / UDI-DI | 00630094430157 |
| Lot numbers | 400514, 400522, 400528, 400530, 400536, 400537, 400540, 400556, 400562, 400565, 400569 |
| Model numbers | CVC015/20 |
Product
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1622-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.