Drug recall
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
FDA recall event 81524 · Class II · Atrium Medical Corporation
Key facts
| Event ID | 81524 |
|---|---|
| Recall numbers | Z-0560-2019 |
| Recalling firm | Atrium Medical Corporation |
| Product type | Devices |
| Products | Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not… |
| Initiation date | Oct 12, 2018 |
| Report date | Dec 12, 2018 |
| Termination date | May 12, 2020 |
| City | Merrimack |
| State | NH |
| Country | United States |
| FEI number | 3011175548 |
At a glance
- 1–9 Products in this recall
- 10–99 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: