Drug recall
Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during…
FDA recall event 87882 · Class II · Nico Corp.
Key facts
| Event ID | 87882 |
|---|---|
| Recall numbers | Z-1839-2021, Z-1840-2021 |
| Recalling firm | Nico Corp. |
| Product type | Devices |
| Products | Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The Myriad-LX light source is a high-intensity 300W Xenon…, NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some… |
| Initiation date | Apr 30, 2021 |
| Report date | Jun 16, 2021 |
| Termination date | Feb 5, 2024 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 3007456622 |
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: