FDA Device recall Z-0469-2015
LUNA Chest, Model No. LU4006
- FDA Device
- Class III
- terminated
- Published 2014-12-03
On 2014-12-03 the FDA classified a Class III recall of LUNA Chest, Model No. LU4006 by Novadaq Technologies, citing non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0469-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-11-04 |
| Published | 2014-12-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Novadaq Technologies |
| Distribution | US |
Product
LUNA Chest, Model No. LU4006
Reason
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Identifiers
| code_info | Kit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0469-2015%22
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