Drug recall
Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison…
FDA recall event 66353 · Class II · ITC-Nexus Dx
Key facts
| Event ID | 66353 |
|---|---|
| Recall numbers | Z-0137-2014 |
| Recalling firm | ITC-Nexus Dx |
| Product type | Devices |
| Products | Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose. |
| Initiation date | Aug 22, 2013 |
| Report date | Nov 13, 2013 |
| Termination date | Jun 9, 2014 |
| City | Edison |
| State | NJ |
| Country | United States |
| FEI number | 2250033 |
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: