Drug recall
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX…
FDA recall event 84826 · Class I · Abbott Vascular
Key facts
| Event ID | 84826 |
|---|---|
| Recall numbers | Z-1128-2020, Z-1129-2020, Z-1130-2020, Z-1131-2020, Z-1132-2020, Z-1133-2020, Z-1134-2020, Z-1135-2020, Z-1136-2020, Z-1137-2020, Z-1138-2020, Z-1139-2020 and 5 more |
| Recalling firm | Abbott Vascular |
| Product type | Devices |
| Products | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United…, NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United…, NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United…, NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United…, NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United… and 11 more |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Initiation date | Jan 29, 2020 |
| Report date | Feb 26, 2020 |
| Termination date | Apr 16, 2024 |
| City | Temecula |
| State | CA |
| Country | United States |
| FEI number | 2024168 |
At a glance
- 10–99 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: