Drug recall
LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
FDA recall event 76476 · Class II · LeMaitre Vascular, Inc.
Key facts
| Event ID | 76476 |
|---|---|
| Recall numbers | Z-1442-2017, Z-1443-2017, Z-1444-2017, Z-1445-2017, Z-1446-2017, Z-1447-2017, Z-1448-2017, Z-1449-2017, Z-1450-2017, Z-1451-2017, Z-1452-2017, Z-1453-2017 |
| Recalling firm | LeMaitre Vascular, Inc. |
| Product type | Devices |
| Products | LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50, LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52, LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51, LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53, LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51 and 7 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Initiation date | Feb 7, 2017 |
| Report date | Mar 22, 2017 |
| Termination date | Sep 20, 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: