FDA Device recall Z-1623-2021
Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)1063009482…
- FDA Device
- Class II
- completed
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class II recall of Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)1063009482… by Bioseal, citing 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 packa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1623-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2021-03-23 |
| Published | 2021-05-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bioseal |
| Distribution | IL, MO |
Product
Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
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.
Identifiers
| code_info | Affected Lot Numbers: 400566, 400561, 400548, 400528 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1623-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.