Drug recall
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N…
FDA recall event 72107 · Class III · CooperSurgical, Inc.
Key facts
| Event ID | 72107 |
|---|---|
| Recall numbers | Z-0105-2016 |
| Recalling firm | CooperSurgical, Inc. |
| Product type | Devices |
| Products | CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%) |
| Initiation date | Sep 1, 2015 |
| Report date | Oct 14, 2015 |
| Termination date | Jan 29, 2016 |
| City | Trumbull |
| State | CT |
| Country | United States |
| FEI number | 1216677 |
At a glance
- 1–9 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: