FDA Device recall Z-0318-2024
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE
- FDA Device
- Class II
- ongoing
- Published 2023-11-22
On 2023-11-22 the FDA classified a Class II recall of Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE by Atrium Medical, citing instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0318-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-18 |
| Published | 2023-11-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Atrium Medical |
| Distribution | US |
Product
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Reason
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains
Identifiers
| code_info | UDI-DI: (1)4000-100N DRAIN, EXPRESS, SINGLE 20650862115134; (2) 4050-100N DRAIN, EXPRESS, BRU 20650862115141 All lots…UDI-DI: (1)4000-100N DRAIN, EXPRESS, SINGLE 20650862115134; (2) 4050-100N DRAIN, EXPRESS, BRU 20650862115141 All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0318-2024%22
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