Drug recall
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on…
FDA recall event 78033 · Class I · OriGen Biomedical, Inc.
Key facts
| Event ID | 78033 |
|---|---|
| Recall numbers | Z-0021-2018 |
| Recalling firm | OriGen Biomedical, Inc. |
| Product type | Devices |
| Products | The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in… |
| Initiation date | Aug 2, 2017 |
| Report date | Nov 1, 2017 |
| Termination date | Feb 29, 2024 |
| City | Austin |
| State | TX |
| Country | United States |
| FEI number | 1000160256 |
At a glance
- 1–9 Products in this recall
- 1–9 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: