Drug recall
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
FDA recall event 71023 · Class II · Atrium Medical Corporation
Key facts
| Event ID | 71023 |
|---|---|
| Recall numbers | Z-1935-2015, Z-1936-2015, Z-1937-2015, Z-1938-2015 |
| Recalling firm | Atrium Medical Corporation |
| Product type | Devices |
| Products | EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N, Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100, Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000, Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Chest drains have a missing o-ring |
| Initiation date | May 7, 2015 |
| Report date | Jul 8, 2015 |
| Termination date | Apr 26, 2016 |
| City | Hudson |
| State | NH |
| Country | United States |
| FEI number | 1219977 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: