Drug recall
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they…
FDA recall event 78754 · Class II · Microline Surgical, Inc.
Key facts
| Event ID | 78754 |
|---|---|
| Recall numbers | Z-0507-2018 |
| Recalling firm | Microline Surgical, Inc. |
| Product type | Devices |
| Products | The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there… |
| Initiation date | Jul 13, 2017 |
| Report date | Feb 14, 2018 |
| Termination date | Feb 6, 2020 |
| City | Beverly |
| State | MA |
| Country | United States |
| FEI number | 1000137656 |
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: