Drug recall
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
FDA recall event 94541 · Class II · Covidien, LLC
Key facts
| Event ID | 94541 |
|---|---|
| Recall numbers | Z-2038-2024 |
| Recalling firm | Covidien, LLC |
| Product type | Devices |
| Products | EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms. |
| Initiation date | Apr 25, 2024 |
| Report date | Jun 19, 2024 |
| City | Santa Clara |
| State | CA |
| Country | United States |
| FEI number | 3004904811 |
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: