Drug recall
Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage…
FDA recall event 86608 · Class II · Micro-Tech Usa
Key facts
| Event ID | 86608 |
|---|---|
| Recall numbers | Z-0470-2021 |
| Recalling firm | Micro-Tech Usa |
| Product type | Devices |
| Products | Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US. |
| Initiation date | Oct 5, 2020 |
| Report date | Nov 25, 2020 |
| Termination date | Dec 2, 2021 |
| City | Ann Arbor |
| State | MI |
| Country | United States |
| FEI number | 3011523880 |
At a glance
- 1–9 Products in this recall
- None 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: