Drug recall
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the…
FDA recall event 72534 · Class II · LeMaitre Vascular, Inc.
Key facts
| Event ID | 72534 |
|---|---|
| Recall numbers | Z-0378-2016, Z-0379-2016, Z-0380-2016, Z-0381-2016, Z-0382-2016, Z-0383-2016, Z-0384-2016, Z-0385-2016, Z-0386-2016, Z-0387-2016, Z-0388-2016, Z-0389-2016 and 1 more |
| Recalling firm | LeMaitre Vascular, Inc. |
| Product type | Devices |
| Products | LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi., LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi., LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi., LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi., LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi. and 8 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Initiation date | Oct 21, 2015 |
| Report date | Dec 16, 2015 |
| Termination date | Jul 12, 2019 |
| City | Burlington |
| State | MA |
| Country | United States |
| FEI number | 1220948 |
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: